Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Atellica CH Diazo Total Bilirubin (D_TBil), Atellica® IM TSH3-Ultra II (TSH3ULII), Atellica IM Total PSA II (tPSAII)
152
Total
151
Cleared
1
Denied
FDA 510(k) Regulatory Record - Siemens Healthcare Diagnostics, Inc. Immunology ✕
29 devices
Cleared
Jan 05, 2026
Atellica IM Total PSA II (tPSAII)
Immunology
222d
Cleared
Dec 04, 2025
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
Immunology
261d
Cleared
Oct 17, 2025
ADVIA Centaur Anti-Thyroid Peroxidase II
Immunology
262d
Cleared
Jun 20, 2025
Atellica IM Thyroglobulin (Tg)
Immunology
267d
Cleared
Mar 17, 2023
RCRP Flex reagent cartridge
Immunology
333d
Cleared
Apr 06, 2020
ADVIA Centaur CA 125II
Immunology
70d
Cleared
Feb 13, 2020
ADVIA Centaur BR
Immunology
58d
Cleared
Jan 15, 2020
ADVIA Centaur Total IgE (tIgE)
Immunology
29d
Cleared
Nov 22, 2019
ADVIA Centaur CA 15-3 assay
Immunology
53d
Cleared
Aug 31, 2017
Atellica IM Ferritin Assay
Immunology
90d
Cleared
Mar 03, 2016
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
Immunology
223d
Cleared
Jan 27, 2015
ADVIA Centaur IgE Master Curve Material
Immunology
34d