Siemens Healthcare Diagnostics Products L T D

FDA Filings

This page includes the latest FDA filings for Siemens Healthcare Diagnostics Products L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
GUDID 00630414637877 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	Atellica IM HBcT2 11643118	2024-05-06
GUDID 00630414604336 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	Atellica IM HBcT2 QC 11200740	2023-06-28
GUDID 00630414604138 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	Atellica IM HBcT2 11200739	2023-06-28
GUDID 00630414561226 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	ADVIA Centaur® HBcT2 10376698	2023-06-28
GUDID 00630414210766 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	ADVIA Centaur® HBcT2 Quality Control Kit 10376699	2023-06-28
GUDID 00630414006345 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 rPru av 1 Specific Allergen A597L2	2022-09-20
GUDID 00630414006291 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 rMal d 4 Specific Allergen A796L2	2022-09-20
GUDID 00630414006284 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 nPru p 3 Specific Allergen A603L2	2022-09-20
GUDID 00630414006277 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 rPru av 4 Specific Allergen A600L2	2022-09-20
GUDID 00630414006253 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 rPru av 3 Specific Allergen A599L2	2022-09-20
GUDID 00630414006246 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 rMal d 1 Specific Allergen A464L2	2022-09-20
GUDID 00630414000138 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 rBet v 2 Specific Allergen A127L2	2022-09-20
PMA P010050S019 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 HBs Ag Confirmatory	2021-06-09
PMA P010053S013 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000/2000 XPi Anti-HBc IgM	2021-03-11
PMA P010051S014 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000/2000 XPi Anti-HBc	2021-03-11
PMN K203270 Siemens Healthcare Diagnostics Products Ltd.	IMMULITE/IMMULITE® 1000 Cortisol	2021-01-15
PMN K202826 Siemens Healthcare Diagnostics Products Ltd.	IMMULITE® 2000 Cortisol	2021-01-15
GUDID 00630414971360 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems T3 Calibration Verification Material Total T3 LT3CVM	2020-10-02
GUDID 00630414971346 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems fPS Calibration Verification Material Free PSA LPFCVM	2020-10-02
GUDID 00630414971339 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems PEP Calibration Verification Material C-Peptide LPEPCVM	2020-10-02
GUDID 00630414971322 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems DPD Calibration Verification Material Pyrilinks-D LPDCVM	2020-10-02
GUDID 00630414971315 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems PAP Calibration Verification Material PAP LPACVM	2020-10-02
GUDID 00630414971308 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems OV Calibration Verification Material OM-MA (CA 125) LOPCVM	2020-10-02
GUDID 00630414971292 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems MYO Calibration Verification Material Myoglobin LMYCVM	2020-10-02
GUDID 00630414971261 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems ALB Calibration Verification Material Albumin LHACVM	2020-10-02
GUDID 00630414971254 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems BP-3 Calibration Verification Material IGBP-3 LGBCVM	2020-10-02
GUDID 00630414971247 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems F4 Calibration Verification Material Free T4 LFT4CVM	2020-10-02
GUDID 00630414971230 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 Systems Folic Acid Calibration Verification Material LFOCVM	2020-10-02
GUDID 00630414971216 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems E2 Calibration Verification Material Estradiol LE2CVM	2020-10-02
GUDID 00630414971193 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE Systems High Sensitivity CRP CVM LCRPCVM	2020-10-02
GUDID 00630414971186 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems CAL Calibration Verification Material Calcitonin LCLCVM	2020-10-02
GUDID 00630414971179 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems CEA Calibration Verification Material LCECVM	2020-10-02
GUDID 00630414971155 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems BR-MA Calibration Verification Material LBRCVM	2020-10-02
GUDID 00630414971148 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems AFP Calibration Verification Material LAPCVM	2020-10-02
GUDID 00630414966557 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems SBG SHBG LKSH1	2020-10-02
GUDID 00630414966298 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems BP3 IGFBP-3 LKGB1	2020-10-02
GUDID 00630414966243 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems INS Insulin LKIN1	2020-10-02
GUDID 00630414966113 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems IGFBP-3 L2KGB2	2020-10-02
GUDID 00630414966045 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems INS Insulin L2KIN2	2020-10-02
GUDID 00630414966014 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems INS Insulin L2KIN6	2020-10-02
GUDID 00630414965741 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems Allergen Tubes L2ATS2	2020-10-02
GUDID 00630414965734 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems Allergen Tube Caps L2ATC	2020-10-02
GUDID 00630414965017 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems SUBS LSUBX	2020-10-02
GUDID 00630414964782 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems TES Total Testosterone LKTW1	2020-10-02
GUDID 00630414964539 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems PRL Prolactin LKPR1	2020-10-02
GUDID 00630414964430 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems PEP C-Peptide LKPEP1	2020-10-02
GUDID 00630414964416 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems DPD Pyrlinks-D LKPD1	2020-10-02
GUDID 00630414964225 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems LH LKLH1	2020-10-02
GUDID 00630414964089 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE/IMMULITE 1000 Systems Growth Hormone (Recombinant 98/574) LKGRH1	2020-10-02
GUDID 00630414964041 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems IG1 IGF-1 LKGF1	2020-10-02
GUDID 00630414964010 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems FSH LKFS1	2020-10-02
GUDID 00630414963884 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems DHS DHEA-SO4 LKDS1	2020-10-02
GUDID 00630414963570 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems AND Androstenedione LKAO1	2020-10-02
GUDID 00630414961989 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems PRG Progesterone L2KPW6	2020-10-02
GUDID 00630414961972 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems PRG Progesterone L2KPW2	2020-10-02
GUDID 00630414961941 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems PRL Prolactin L2KPR6	2020-10-02
GUDID 00630414961934 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems PRL Prolactin L2KPR2	2020-10-02
GUDID 00630414961873 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems C-Peptide L2KPEP2	2020-10-02
GUDID 00630414961859 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems DPD Pyrlinks-D L2KPD2	2020-10-02
GUDID 00630414961705 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems LH L2KLH6	2020-10-02
GUDID 00630414961552 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems Growth Hormone (Recombinant 98/574) L2KGRH2	2020-10-02
GUDID 00630414961538 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems IGF-1 L2KGF2	2020-10-02
GUDID 00630414961521 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems GAS Gastrin L2KGA2	2020-10-02
GUDID 00630414961514 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems FSH L2KFS6	2020-10-02
GUDID 00630414961507 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems FSH L2KFS2	2020-10-02
GUDID 00630414961309 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems DHS DHEA-SO4 L2KDS2	2020-10-02
GUDID 00630414961026 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems AND Androstenedione L2KAO2	2020-10-02
GUDID 00630414960951 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 1000 System ID1 IgG/IgM Sample Diluent L1KIGW1	2020-10-02
GUDID 00630414954226 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems SBG SHBG Sample Diluent LSHZ	2020-10-02
GUDID 00630414954202 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems DPD Pyrilinks-D Sample Diluent LPDZ	2020-10-02
GUDID 00630414954172 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems PRL Prolactin Sample Diluent LPRZ	2020-10-02
GUDID 00630414954035 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems INS Insulin Sample Diluent L2INZ	2020-10-02
GUDID 00630414954028 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® Systems 1000 Systems INS Insulin Sample Diluent LINZ	2020-10-02
GUDID 00630414953922 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems IG1 IGF-I Sample Diluent L2GFZ	2020-10-02
GUDID 00630414953809 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems GH Growth Hormone Sample Diluent LGHZ	2020-10-02
GUDID 00630414953786 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems FSH FSH Sample Diluent L2FSZ	2020-10-02
GUDID 00630414953779 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems FSH Sample Diluent LFSZ	2020-10-02
GUDID 00630414953724 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems E2 Estradiol Sample Diluent LE2Z	2020-10-02
GUDID 00630414953694 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems DHS DHEASO4 Sample Diluent LDSZ	2020-10-02
GUDID 00630414953663 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems PEP C-Peptide Sample Diluent L2PEZ	2020-10-02
GUDID 00630414953656 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems PEP C-Peptide Sample Diluent LPEZ	2020-10-02
GUDID 00630414953311 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems TSH CONTROL Third Generation TSH LTGCM	2020-10-02
GUDID 00630414953281 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems PDP CONTROL Pyrilinks-D LPDCM	2020-10-02
GUDID 00630414953212 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems IG1 CONTROL IGF-1 LGCOCM	2020-10-02
GUDID 00630414953199 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems GAS CONTROL Gastrin LGACM	2020-10-02
GUDID 00630414953007 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems CPE CONTROL C-Peptide PECM	2020-10-02
GUDID 00630414947921 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE Systems Unconjugated Estriol (uE3) CVM LUE3CVM(D)	2020-10-02
GUDID 00630414947914 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems E2 Estradiol L2KE26(D)	2020-10-02
GUDID 00630414947907 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems E2 Estradiol L2KE22(D)	2020-10-02
GUDID 00630414947891 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems E2 Estradiol LKE21(D)	2020-10-02
GUDID 00630414601946 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® Systems PTS Calibration Verification Material PSA LPTSCVM	2020-10-02
GUDID 00630414601939 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 3RD GEN. PSA CVM L3PSCVM	2020-10-02
GUDID 00630414601243 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE®/IMMULITE® 1000 Systems IGF-I LKIGF1	2020-10-02
GUDID 00630414601236 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 Systems IGF-I L2KIGF2	2020-10-02
GUDID 00630414167718 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 Progesterone Kit Domestic 200T L2KPW2(D)	2020-10-02
GUDID 00630414167510 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 Progesterone Kit Domestic 600T L2KPW6(D)	2020-10-02
GUDID 00630414167503 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 Prolactin Kit Domestic 600T L2KPR6(D)	2020-10-02
GUDID 00630414167497 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 Prolactin Kit Domestic 200T L2KPR2(D)	2020-10-02
GUDID 00630414167480 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 LH Kt Domestic 600T L2KLH6(D)	2020-10-02
GUDID 00630414167459 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 LH Kit Domestic 200T L2KLH2(D)	2020-10-02
GUDID 00630414167442 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 FSH Kit Domestic 600T L2KFS6(D)	2020-10-02
GUDID 00630414167435 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 FSH Kit Domestic 200T L2KFS2(D)	2020-10-02
GUDID 00630414167428 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE 2000 DHEAS Kit Domestic 200T L2KDS2(D)	2020-10-02
GUDID 00630414006680 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® 2000 TSI CVM L2SICVM	2020-10-02
GUDID 00630414000213 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD	IMMULITE® GROWTH HORMONE CVM LGRHCVM	2020-10-02
PMA P010053S012 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 Anti-HBcM	2020-09-08
PMA P010052S014 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 Anti-HBs	2020-09-08
PMA P010051S013 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 Anti-HBc	2020-09-08
PMA P010050S018 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 HBsAg Confirmatory	2020-09-08
PMA P010053S011 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 Anti HBc IgM	2019-12-19
PMA P010052S013 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 Anti-HBs	2019-12-19
PMA P010051S012 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 Anti-HBc	2019-12-19
PMA P010050S017 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 HBsAg & HBs Ag Confirmatory	2019-12-19
PMA P010052S012 Siemens Healthcare Diagnostics Products, LTD	IMMULITE ANTI-HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) SYSTEMS	2015-07-27
PMA P010050S016 Siemens Healthcare Diagnostics Products, LTD	IMMULITE HBSAG, IMMULITE 2000 HBSAG	2014-11-18
PMA P010053S010 Siemens Healthcare Diagnostics Products, LTD	ANTI-HBCM IMMULITE SUBSTRATE REAGENT	2012-03-27
PMA P010052S011 Siemens Healthcare Diagnostics Products, LTD	ANTI-HBS IMMULITE SUBSTRATE REAGENT	2012-03-27
PMA P010051S011 Siemens Healthcare Diagnostics Products, LTD	ANTI-HBC IMMULITE SUBSTRATE REAGENT	2012-03-27
PMA P010050S015 Siemens Healthcare Diagnostics Products, LTD	HBSAG IMMULITE SUBSTRATE REAGENT	2012-03-27
PMA P010053S009 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC	2011-09-13
PMA P010052S010 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS	2011-09-13
PMA P010051S010 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC	2011-09-13
PMA P010050S014 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 2000 HBSAG CONFIRMATORY	2011-09-13
PMA P010053S008 Siemens Healthcare Diagnostics Products, LTD	ANTI-HBCM IMMULITE ASSAY	2011-09-02
PMA P010052S009 Siemens Healthcare Diagnostics Products, LTD	ANTI-HBS IMMULITE ASSAY	2011-09-02
PMA P010051S009 Siemens Healthcare Diagnostics Products, LTD	ANTI-HBC IMMULITE ASSAY	2011-09-02
PMA P010050S013 Siemens Healthcare Diagnostics Products, LTD	HBSAG IMMULITE ASSAY	2011-09-02
PMA P010050S011 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 HBS AG CONFIRMATORY KIT	2011-06-24
PMA P010053S007 Siemens Healthcare Diagnostics Products, LTD	ANTI-HBC IGM	2011-05-12
PMA P010052S008 Siemens Healthcare Diagnostics Products, LTD	ANTI-HBS	2011-05-12
PMA P010051S008 Siemens Healthcare Diagnostics Products, LTD	ANTI-HBC	2011-05-12
PMA P010050S012 Siemens Healthcare Diagnostics Products, LTD	HBSAG	2011-05-12
PMA P010053S006 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC IGM	2010-01-20
PMA P010052S007 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS	2010-01-20
PMA P010051S007 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC	2010-01-20
PMA P010050S010 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & IMMULITE/IMMULITE 1000/IMMULITE 2000 HBSAG CONFIRMATORY	2010-01-20
PMA P010052S004 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS	2009-12-16
PMA P010050S008 Siemens Healthcare Diagnostics Products, LTD	IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY	2009-06-02
PMA P010050S007 Siemens Healthcare Diagnostics Products, LTD	IMMULITE & IMMULITE 2000 HBSAG ASSAY	2009-02-09
PMA P010053S004 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM	2008-12-16
PMA P010052S005 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS	2008-12-16
PMA P010051S005 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC	2008-12-16
PMA P010050S006 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000, IMMULITE 2000 HBSAG/HBSAG CONFIMATORY	2008-12-16
PMA P010050S005 Siemens Healthcare Diagnostics Products, LTD	IMMULITE / IMMULITE 1000 HBSAG & IMMULITE 2000 HBSAG	2006-09-01
PMA P010051S004 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC ASSAYS	2006-06-16
PMA P010053S003 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM	2005-11-02
PMA P010052S003 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS	2005-11-02
PMA P010051S003 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC	2005-11-02
PMA P010050S003 Siemens Healthcare Diagnostics Products, LTD	IMMULITE/ IMMULITE 1000 AND IMMULITE 2000 HBSAG KITS.	2003-06-11
PMA P010053S001 Siemens Healthcare Diagnostics Products, LTD	IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC	2003-03-13
PMA P010052S001 Siemens Healthcare Diagnostics Products, LTD	IMMULITE, IMMULITE 1000 ANTI-HBS AND IMMULITE 2000 ANTI-HBS	2003-03-13
PMA P010051S001 Siemens Healthcare Diagnostics Products, LTD	IMMULITE, IMMULITE 1000 ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBCIGM	2003-03-13
PMA P010050S001 Siemens Healthcare Diagnostics Products, LTD	IMMULITE,IMMULITE 1000 HBSAG,CONFIRMATORY AND IMMULITE 2000 HBSAG,CONFIRMATORY KIT	2003-03-13
PMA P010053 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 XPI ANTI-HBC IMG	2002-07-26
PMA P010050 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 XPI HBSAG	2002-07-26
PMA P010051 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 XPI ANTI-HBC	2002-07-24
PMA P010052 Siemens Healthcare Diagnostics Products, LTD	IMMULITE 2000 XPI ANTI-HBS	2002-07-22

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• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010050 Supplement NumberS021 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010053 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010051 Supplement NumberS017 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010052 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010051 Supplement NumberS015 Date Received02/28/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010053 Supplement NumberS014 Date Received02/28/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No