Atlas FDA

Siemens Healthcare Diagnostics

252 FDA 510(k) clearances · PMA applicant

Sort:Newest firstOldest first

◉ Watch Siemens Healthcare Diagnostics

RecordFirmDate
Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024)Siemens Healthcare Diagnostics2025-10-17
Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S013)Siemens Healthcare Diagnostics2025-10-17
ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (P950021/S030)Siemens Healthcare Diagnostics2025-07-16
ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029)Siemens Healthcare Diagnostics2025-07-16
Dimension TPSA Flex reagent cartridge (P000021/S047)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S042)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S041)Siemens Healthcare Diagnostics2025-02-24
Dimension TPSA Flex reagent cartridge (P000021/S046)Siemens Healthcare Diagnostics2025-02-24
Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S012)Siemens Healthcare Diagnostics2025-01-13
Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S023)Siemens Healthcare Diagnostics2024-12-17
Atellica IM Prostate-Specific Antigen (PSA) (P950021/S029)Siemens Healthcare Diagnostics2024-09-23
Atellica IM Complexed PSA (cPSA) (P990055/S028)Siemens Healthcare Diagnostics2024-09-23
Atelica IM Prostate-Specific Antigen (PSA) (P950021/S026)Siemens Healthcare Diagnostics2024-05-15
Atellica IM complexed PSA (cPSA) (P990055/S025)Siemens Healthcare Diagnostics2024-02-13
ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA (P950021/S027)Siemens Healthcare Diagnostics2023-12-18
ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA (P990055/S026)Siemens Healthcare Diagnostics2023-12-18
Dimension® TPSA Flex® reagent cartridge (P000021/S045)Siemens Healthcare Diagnostics2023-09-26
Dimension® FPSA Flex® reagent cartridge (P020027/S040)Siemens Healthcare Diagnostics2023-09-26
ADVIA Centaur® and Atellica IM Hepatitis B Core IgM (AHBcM) Assay (P030040/S022)Siemens Healthcare Diagnostics2023-02-06
Atellica® IM Anti-Hepatitis B core Total (HBcT) Assay (P040004/S021)Siemens Healthcare Diagnostics2022-03-29
Atellica® IM Prostate-Specific Antigen (PSA) Assay (P950021/S025)Siemens Healthcare Diagnostics2022-03-29
Atellica® IM Hepatitis B core IgM (aHBcM) Assay (P030040/S021)Siemens Healthcare Diagnostics2022-03-29
Atellica® IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S011)Siemens Healthcare Diagnostics2022-03-29
Atellica® IM Complexed PSA (cPSA) Assay (P990055/S024)Siemens Healthcare Diagnostics2022-03-29
Dimension® TPSA Flex® reagent cartridge (P000021/S044)Siemens Healthcare Diagnostics2021-12-20
Dimension® FPSA Flex® reagent cartridge (P020027/S039)Siemens Healthcare Diagnostics2021-12-20
Dimension Vista FPSA Flex reagent cartridge (P020027/S037)Siemens Healthcare Diagnostics2021-10-08
Dimension Vista TPSA Flex reagent cartridge (P000021/S042)Siemens Healthcare Diagnostics2021-10-08
Atellica IM Anti-Hepatitis B core Total (HBcT) Assay (P040004/S020)Siemens Healthcare Diagnostics2021-04-27
Atellica IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S010)Siemens Healthcare Diagnostics2021-04-27
Atellica IM Complexed PSA (cPSA) Assay (P990055/S023)Siemens Healthcare Diagnostics2021-04-27
Atellica IM Prostate-Specific Antigen (PSA) Assay (P950021/S024)Siemens Healthcare Diagnostics2021-04-27
Atellica IM Hepatitis B core IgM (aHBcM) Assay (P030040/S020)Siemens Healthcare Diagnostics2021-04-27
Atellica IM Hepatitis C (aHCV) Assay (P030056/S020)Siemens Healthcare Diagnostics2021-04-27
ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He (P030040/S019)Siemens Healthcare Diagnostics2021-03-11
ADVIA Centaur HBc Total ReadyPack Reagents, ADVIA Centaur HBc Total Quality Control Materials, Atellica IM Anti-Hepatiti (P040004/S019)Siemens Healthcare Diagnostics2021-03-11
ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality (P030049/S016)Siemens Healthcare Diagnostics2021-03-11
ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC) (P030056/S019)Siemens Healthcare Diagnostics2021-03-11
ADVIA Centaur PSA Readypack Reagents (P950021/S023)Siemens Healthcare Diagnostics2020-10-27
Dimension Vista TPSA Flex reagent cartridge (P000021/S043)Siemens Healthcare Diagnostics2020-10-13
Dimension Vista FPSA Flex reagent cartridge (P020027/S038)Siemens Healthcare Diagnostics2020-10-13
ADVIA Centaur HBeAg Readypack Reagents and Quality Control Material (P090024/S009)Siemens Healthcare Diagnostics2020-08-25
ADVIA Centaur HBsAg/Confirmatory Readypack Reagents, Calibrators and Controls (P030049/S015)Siemens Healthcare Diagnostics2020-08-25
ADVIA Centaur HBc Total Readypack Reagents and Quality COntrol Materials (P040004/S018)Siemens Healthcare Diagnostics2020-08-25
ADVIA Centaur cPSA Readypack Reagents (P990055/S022)Siemens Healthcare Diagnostics2020-08-25
ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials (P030056/S018)Siemens Healthcare Diagnostics2020-08-25
ADVIA Centaur HBc IgM Readypack Reagents and Quality Control Material (P030040/S018)Siemens Healthcare Diagnostics2020-08-25
ADVIA Centaur PSA Readypack Reagents (P950021/S022)Siemens Healthcare Diagnostics2020-08-25
Advia Centaur PSA Immunoassay and Atellica IM PSA Immunoassay (P950021/S019)Siemens Healthcare Diagnostics2020-07-02
Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay (P990055/S019)Siemens Healthcare Diagnostics2020-07-02
ADVIA Centaur HCV, and Atellica HCV (P030056/S017)Siemens Healthcare Diagnostics2020-06-21
Atellica IM Hepatitis B core IgM (aHBcM) Assay (P030040/S017)Siemens Healthcare Diagnostics2020-04-03
Atellica IM Anti-Hepatitis B core Total (HBcT) Assay (P040004/S017)Siemens Healthcare Diagnostics2020-04-03
Atellica IM Prostate-Specific Antigen (PSA) Assay (P950021/S021)Siemens Healthcare Diagnostics2020-04-03
Atellica IM Complexed PSA (cPSA) Assay (P990055/S021)Siemens Healthcare Diagnostics2020-04-03
Atellica IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S008)Siemens Healthcare Diagnostics2020-04-03
Atellica IM Hepatitis C (aHCV) Assay (P030056/S016)Siemens Healthcare Diagnostics2020-04-03
ADVIA Centaur and Atellica IM HBeAg (P090024/S007)Siemens Healthcare Diagnostics2020-03-19
ADVIA Centaur HBsAg (P030049/S014)Siemens Healthcare Diagnostics2020-03-19
ADVIA Centaur and Atellica IM HBc IgM (P030040/S016)Siemens Healthcare Diagnostics2020-03-19
ADVIA Centaur and Atellica IM PSA (P950021/S020)Siemens Healthcare Diagnostics2020-03-19
ADVIA Centaur and Atellica IM cPSA (P990055/S020)Siemens Healthcare Diagnostics2020-03-19
ADVIA Centaur and Atellica IM HBc Total (P040004/S016)Siemens Healthcare Diagnostics2020-03-19
ADVIA Centaur and Atellica IM HCV (P030056/S015)Siemens Healthcare Diagnostics2020-03-19
ADVIA Centaur HBsAg (P030049/S013)Siemens Healthcare Diagnostics2019-10-25
ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA (P950021/S018)Siemens Healthcare Diagnostics2019-07-25
Dimension Vista TPSA Flex reagent cartridge (K6452) (P020027/S036)Siemens Healthcare Diagnostics2019-06-26
Dimension Vista TPSA Flex reagent cartridge (K6451) (P000021/S041)Siemens Healthcare Diagnostics2019-06-26
Dimension FPSA Flex reagent cartridge (P020027/S035)Siemens Healthcare Diagnostics2019-06-20
Dimension TPSA Flex reagent cartridge (P000021/S040)Siemens Healthcare Diagnostics2019-06-20
Atellica IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S006)Siemens Healthcare Diagnostics2019-03-08
Atellica Im Anti-Hepatitis B core Total (HBcT) Assay (P040004/S015)Siemens Healthcare Diagnostics2019-03-08
Atellica IM Prostate-Specific Antigen (PSA) Assay (P950021/S017)Siemens Healthcare Diagnostics2019-03-08
Atellica IM Hepatitis C (aHCV) Assay (P030056/S014)Siemens Healthcare Diagnostics2019-03-08
Atellica IM Complexed PSA (cPSA) Assay (P990055/S018)Siemens Healthcare Diagnostics2019-03-08
Atellica IM Hepatitis B orfe IgM (aHBcM) Assay (P030040/S015)Siemens Healthcare Diagnostics2019-03-08
Dimension Vista FPSA Flex reagent cartridge (P020027/S034)Siemens Healthcare Diagnostics2018-12-27
Dimension Vista TPSA Flex reagent cartridge (P000021/S039)Siemens Healthcare Diagnostics2018-12-27
Atellica IM Complexed PSA (cPSA) (P990055/S017)Siemens Healthcare Diagnostics2018-10-25
Atellica IM Prostate-Specific Antigen (PSA) (P950021/S016)Siemens Healthcare Diagnostics2018-10-25
Atellica IM anti-HBc Total (HBcT) (P040004/S014)Siemens Healthcare Diagnostics2018-09-11
Atellica IM Analyzer Hepatitis C (aHCV) (P030056/S013)Siemens Healthcare Diagnostics2018-09-11
Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S005)Siemens Healthcare Diagnostics2018-09-11
Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S013)Siemens Healthcare Diagnostics2018-09-11
Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC) (P030040/S014)Siemens Healthcare Diagnostics2018-08-24
Atellica IM Prostate-Specific Antigen (PSA) (P950021/S015)Siemens Healthcare Diagnostics2018-08-03
Atellica IM CPSA Assay (P990055/S016)Siemens Healthcare Diagnostics2018-08-03
Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S004)Siemens Healthcare Diagnostics2018-07-12
Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC) (P040004/S013)Siemens Healthcare Diagnostics2018-07-06
Dimension Vista TPSA Flex reagent cartridge (K6451) (P000021/S038)Siemens Healthcare Diagnostics2018-07-05
Dimension Vista FPSA Flex reagent cartridge (K6452) (P020027/S033)Siemens Healthcare Diagnostics2018-07-05
Dimension TPSA Flex Reagent Cartridge (P000021/S037)Siemens Healthcare Diagnostics2018-05-14
Dimension FPSA Flex Reagent Cartidge (P020027/S032)Siemens Healthcare Diagnostics2018-05-14
Atellica IM Hepatitis C (aHCV) (P030056/S011)Siemens Healthcare Diagnostics2018-05-09
Atellica IM Hepatitis B core Antigen (aHBcM) (P030040/S012)Siemens Healthcare Diagnostics2018-05-03
Dimension TPSA Flex Reagent Cartridge (P000021/S033)Siemens Healthcare Diagnostics2018-04-13
Dimension FPSA Flex Reagent Cartridge (P020027/S028)Siemens Healthcare Diagnostics2018-04-13
Dimension Vista TPSA Flex reagent cartridge (K6451) (P000021/S035)Siemens Healthcare Diagnostics2017-12-15
Dimension Vista FPSA Flex reagent cartridge (K6452) (P020027/S030)Siemens Healthcare Diagnostics2017-12-15
Dimension Vista FPSA Flex reagent cartridge (P020027/S029)Siemens Healthcare Diagnostics2017-11-14
Next →

Track Siemens Healthcare Diagnostics automatically

Every clearance here is in the API, with alerts when new ones post.