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
DeviceDate
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HCV, and Atellica HCV2020-06-21
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Complexed PSA (cPSA) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Prostate-Specific Antigen (PSA) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Anti-Hepatitis B core Total (HBcT) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis C (aHCV) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B core IgM (aHBcM) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM cPSA2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM PSA2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HBeAg2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HBc Total2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HCV2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBsAg2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HBc IgM2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBsAg2019-10-25
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA2019-07-25
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge (K6452)2019-06-26
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge (K6451)2019-06-26
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension FPSA Flex reagent cartridge2019-06-20
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension TPSA Flex reagent cartridge2019-06-20
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Complexed PSA (cPSA) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Prostate-Specific Antigen (PSA) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica Im Anti-Hepatitis B core Total (HBcT) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis C (aHCV) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B orfe IgM (aHBcM) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista FPSA Flex reagent cartridge2018-12-27
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge2018-12-27
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Complexed PSA (cPSA)2018-10-25
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Prostate-Specific Antigen (PSA)2018-10-25
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM anti-HBc Total (HBcT)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Analyzer Hepatitis C (aHCV)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B core IgM (aHBcM)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)2018-08-24
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM CPSA Assay2018-08-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Prostate-Specific Antigen (PSA)2018-08-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg)2018-07-12
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)2018-07-06
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista FPSA Flex reagent cartridge (K6452)2018-07-05
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge (K6451)2018-07-05
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension FPSA Flex Reagent Cartidge2018-05-14
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension TPSA Flex Reagent Cartridge2018-05-14
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis C (aHCV)2018-05-09
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B core Antigen (aHBcM)2018-05-03
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension FPSA Flex Reagent Cartridge2018-04-13
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension TPSA Flex Reagent Cartridge2018-04-13
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista FPSA Flex reagent cartridge (K6452)2017-12-15
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge (K6451)2017-12-15
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista FPSA Flex reagent cartridge2017-11-14
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge2017-11-14
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA 2120i, ADVIA 21202017-08-11
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA CENTAUR PSA ASSAY2017-07-27
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension FPSA Flex reagent cartridge (RF451)2017-07-17
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension TPSA Flex reagent cartridge (RF451)2017-07-17
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension FPSA Flex reagent cartridge (RF452)2017-05-22
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension TPSA Flex reagent cartridge (RF451)2017-05-22
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBeAg2017-04-25
SIEMENS HEALTHCARE DIAGNOSTICS
LOCI Total Vitamin D Total Assay, LOCI VITD CAL2017-03-16
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension FPSA Flex reagent cartridge2017-03-16
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension TPSA Flex reagent cartridge2017-03-16
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
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS2016-12-25
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator2016-11-17
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA CENTAUR CPSA ASSAY2016-10-24
SIEMENS HEALTHCARE DIAGNOSTICS
DIMENSION VISTA FPSA ASSAY2016-10-19
SIEMENS HEALTHCARE DIAGNOSTICS
DIMENSION VISTA TPSA ASSAY2016-10-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY2016-10-18
SIEMENS HEALTHCARE DIAGNOSTICS
Xprecia Stride Coagulation System, Xprecia System PT Controls2016-09-30
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur® HCV assay2016-09-09
SIEMENS HEALTHCARE DIAGNOSTICS
DIMENSION FPSA FLEX REAGENT CARTRIDGE (RF452)2016-08-30
SIEMENS HEALTHCARE DIAGNOSTICS
DIMENSION TPSA FLEX REAGENT CARTRIDGE (RF451)2016-08-30
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA CENTAUR HBC TOTAL ASSAY2016-08-11
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA CENTAUR AHBCM ASSAY2016-03-11
SIEMENS HEALTHCARE DIAGNOSTICS
DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE2015-12-15
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)2015-11-04
Siemens Healthcare Diagnostics
Dimension Vista MMB Assay2015-09-18
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex Reagent Cartridge (MG)2015-06-15
Siemens Healthcare Diagnostics
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module2015-04-13
Siemens Healthcare Diagnostics
IMMULITE 2000 CEA Calibration Verification Material2015-01-23
SIEMENS HEALTHCARE DIAGNOSTICS
CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT2014-11-17

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