Siemens Healthcare Diagnostics

FDA Filings

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

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMA P020027S039 SIEMENS HEALTHCARE DIAGNOSTICS	Dimension® FPSA Flex® reagent cartridge	2021-12-20
PMA P000021S044 SIEMENS HEALTHCARE DIAGNOSTICS	Dimension® TPSA Flex® reagent cartridge	2021-12-20
PMA P990055S023 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Complexed PSA (cPSA) Assay	2021-04-27
PMA P950021S024 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Prostate-Specific Antigen (PSA) Assay	2021-04-27
PMA P090024S010 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Hepatitis B e Antigen (HBeAg) Assay	2021-04-27
PMA P040004S020 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Anti-Hepatitis B core Total (HBcT) Assay	2021-04-27
PMA P030056S020 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Hepatitis C (aHCV) Assay	2021-04-27
PMA P030040S020 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Hepatitis B core IgM (aHBcM) Assay	2021-04-27
PMA P040004S019 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur HBc Total ReadyPack Reagents, ADVIA Centaur HBc Total Quality Control Materials, Atellica IM Anti-Hepatiti	2021-03-11
PMA P030056S019 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)	2021-03-11
PMA P030049S016 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality	2021-03-11
PMA P030040S019 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He	2021-03-11
PMA P950021S023 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur PSA Readypack Reagents	2020-10-27
PMA P020027S038 SIEMENS HEALTHCARE DIAGNOSTICS	Dimension Vista FPSA Flex reagent cartridge	2020-10-13
PMA P000021S043 SIEMENS HEALTHCARE DIAGNOSTICS	Dimension Vista TPSA Flex reagent cartridge	2020-10-13
PMA P990055S022 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur cPSA Readypack Reagents	2020-08-25
PMA P950021S022 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur PSA Readypack Reagents	2020-08-25
PMA P090024S009 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur HBeAg Readypack Reagents and Quality Control Material	2020-08-25
PMA P040004S018 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur HBc Total Readypack Reagents and Quality COntrol Materials	2020-08-25
PMA P030056S018 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials	2020-08-25
PMA P030049S015 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur HBsAg/Confirmatory Readypack Reagents, Calibrators and Controls	2020-08-25
PMA P030040S018 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur HBc IgM Readypack Reagents and Quality Control Material	2020-08-25
PMA P030056S017 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur HCV, and Atellica HCV	2020-06-21
PMA P990055S021 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Complexed PSA (cPSA) Assay	2020-04-03
PMA P950021S021 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Prostate-Specific Antigen (PSA) Assay	2020-04-03
PMA P090024S008 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Hepatitis B e Antigen (HBeAg) Assay	2020-04-03
PMA P040004S017 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Anti-Hepatitis B core Total (HBcT) Assay	2020-04-03
PMA P030056S016 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Hepatitis C (aHCV) Assay	2020-04-03
PMA P030040S017 SIEMENS HEALTHCARE DIAGNOSTICS	Atellica IM Hepatitis B core IgM (aHBcM) Assay	2020-04-03
PMA P990055S020 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur and Atellica IM cPSA	2020-03-19
PMA P950021S020 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur and Atellica IM PSA	2020-03-19
PMA P090024S007 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur and Atellica IM HBeAg	2020-03-19
PMA P040004S016 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur and Atellica IM HBc Total	2020-03-19
PMA P030056S015 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur and Atellica IM HCV	2020-03-19
PMA P030049S014 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur HBsAg	2020-03-19
PMA P030040S016 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur and Atellica IM HBc IgM	2020-03-19
PMA P030049S013 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur HBsAg	2019-10-25
PMA P950021S018 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA	2019-07-25
PMA P020027S036 SIEMENS HEALTHCARE DIAGNOSTICS	Dimension Vista TPSA Flex reagent cartridge (K6452)	2019-06-26
PMA P000021S041 SIEMENS HEALTHCARE DIAGNOSTICS	Dimension Vista TPSA Flex reagent cartridge (K6451)	2019-06-26
PMA P020027S035 SIEMENS HEALTHCARE DIAGNOSTICS	Dimension FPSA Flex reagent cartridge	2019-06-20
PMA P000021S040 SIEMENS HEALTHCARE DIAGNOSTICS	Dimension TPSA Flex reagent cartridge	2019-06-20
PMN K162977 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA 2120i, ADVIA 2120	2017-08-11
PMN K162298 SIEMENS HEALTHCARE DIAGNOSTICS	LOCI Total Vitamin D Total Assay, LOCI VITD CAL	2017-03-16
PMN K161954 Siemens Healthcare Diagnostics	Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)	2017-03-09
PMN K162538 SIEMENS HEALTHCARE DIAGNOSTICS	ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator	2016-11-17
PMN K151964 SIEMENS HEALTHCARE DIAGNOSTICS	Xprecia Stride Coagulation System, Xprecia System PT Controls	2016-09-30
PMN K150168 SIEMENS HEALTHCARE DIAGNOSTICS	Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)	2015-11-04
PMN K143720 Siemens Healthcare Diagnostics	Dimension Vista MMB Assay	2015-09-18
PMN K140790 SIEMENS HEALTHCARE DIAGNOSTICS	Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex Reagent Cartridge (MG)	2015-06-15
PMN K150132 Siemens Healthcare Diagnostics	IMMULITE IGF Control Module, IMMULITE Gastrin Control Module	2015-04-13
PMN K143639 Siemens Healthcare Diagnostics	IMMULITE 2000 CEA Calibration Verification Material	2015-01-23
PMN K140717 SIEMENS HEALTHCARE DIAGNOSTICS	CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT	2014-11-17

Similar & Related FDA Registered Companies

SIEMENS HEALTHCARE DIAGNOSTICS INC
Siemens Healthcare Diagnostics Products GmbH
Siemens Healthcare Diagnostics Products Ltd.
SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH
Siemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591 PMA NumberP210019 Supplement NumberS001 Date Received08/01/2022 Decision Date12/20/2022 Product Code LOM Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
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 INC.glyn Rhonwy, Llanberisgwynedd Ll55 4el LL554 PMA NumberP930027 Supplement NumberS028 Date Received09/15/2022 Decision Date10/14/2022 Product Code MTF Advisory Committee Immunology 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 INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP010007 Supplement NumberS017 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOK Advisory Committee Immunology 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 INC.333 Coney Streeteast Walpole, MA 02032 PMA NumberP930036 Supplement NumberS020 Date Received09/01/2022 Decision Date09/30/2022 Product Code LOK Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Siemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591 PMA NumberP210019 Date Received05/11/2021 Decision Date07/27/2022 Product Code LOM Advisory Committee Microbiology Expedited Review Granted? No
Siemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591-5097 PMA NumberP200017 Supplement NumberS002 Date Received03/22/2022 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 DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP030040 Supplement NumberS021 Date Received03/22/2022 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 DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP040004 Supplement NumberS021 Date Received03/22/2022 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 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 DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP950021 Supplement NumberS025 Date Received03/22/2022 Decision Date03/29/2022 Product Code MTG Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP990055 Supplement NumberS024 Date Received03/22/2022 Decision Date03/29/2022 Advisory Committee Immunology 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
SIEMENS HEALTHCARE DIAGNOSTICS INC.glyn Rhonwy, Llanberisgwynedd Ll55 4el LL554 PMA NumberP930027 Supplement NumberS026 Date Received02/28/2022 Decision Date03/29/2022 Product Code MTF Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP100039 Supplement NumberS015 Date Received03/22/2022 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 DIAGNOSTICS511 Benedict Avenuetarrytown, NY 10591 PMA NumberP090024 Supplement NumberS011 Date Received03/22/2022 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 INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP010007 Supplement NumberS015 Date Received02/28/2022 Decision Date03/29/2022 Product Code LOK Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS INC.333 Coney Streeteast Walpole, MA 02032 PMA NumberP930036 Supplement NumberS019 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOK Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	F3557	SIEMENS HEALTHCARE DIAGNOSTICS
CAGE Code	F3557	SIEMENS HEALTHCARE DIAGNOSTICS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092998694	Anvers,Belgium -> Norfolk, Virginia	DIAGNOSTICA HS CODES 38220000, 30021500, 39269097, 90279000 .	50 PCS
20200929105675	Stadersand,Federal Republic of Germany -> New York, New York	SLAC ON 2 PALLETS . PLASTIC BOTTLES WITH EXTR USIONS-BLOW MOULDING AS PER PROFORMA INVOICE-	30 PCS
2020092642934	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	PACKING MATERIAL PACKING MATERIAL INVOICE NO MED/ EXP/DX/037 DT. 06.02.2020 SBILL NO 9618459 DT.13/01/2020 HS CODE 48195090 NET.WT 5472.00 KGS	18 PCS
2020092677687	Stadersand,Federal Republic of Germany -> New York, New York	SLAC ON 2 PALLETS . PLASTIC BOTTLES WITH EXTR USIONS-BLOW MOULDING AS PER PROFORMA INVOICE-	30 PCS
2020092459655	Stadersand,Federal Republic of Germany -> New York, New York	SLAC ON 2 PALLETS . PLASTIC BOTTLES WITH EXTR USIONS-BLOW MOULDING AS PER PROFORMA INVOICE-	30 PCS
2020092382493	Stadersand,Federal Republic of Germany -> New York, New York	SLAC ON 2 PALLETS . PLASTIC BOTTLES WITH EXTR USIONS-BLOW MOULDING AS PER PROFORMA INVOICE-	30 PCS
202009222580	Le Havre,France -> New York/Newark Area, Newark, New Jersey	UN1230 CLASS 3(6.1) GEII	1479 BOX
202009222580	Le Havre,France -> New York/Newark Area, Newark, New Jersey	UN1230 CLASS 3(6.1) GEII	1479 BOX
202009222580	Le Havre,France -> New York/Newark Area, Newark, New Jersey	HARMLESS GOODS DIFF QUICK SOLUTIONS	1479 BOX
202009222580	Le Havre,France -> New York/Newark Area, Newark, New Jersey	UN1230 CLASS 3(6.1) GEII	1479 BOX