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Siemens Healthcare Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 72 products

Total Devices72
Categories49
Latest FDA decision2026-08-10
TypeNumberDevice NameCodeDateActions
510(k) K163658 ADVIA Centaur Intact Parathyroid Hormone (PTH) AssayCEW2017-05-23 View
510(k) K163220 Atellica CH Phencyclidine (Pcp)LCM2017-04-06 View
510(k) K170065 ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)JFM2017-03-09 View
510(k) K162399 Atellica CH Magnesium (Mg)JGJ2017-01-19 View
510(k) K161494 Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)CGX2016-11-15 View
510(k) K161964 ADVIA Centaur HAV IgM AssayLOL2016-10-13 View
510(k) K160724 ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorCGS2016-09-07 View
510(k) K151986 ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve MaterialCDZ2016-06-29 View
510(k) K160647 IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4JLW2016-05-31 View
510(k) K160202 Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)LEH2016-04-27 View
510(k) K152061 IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialJZO2016-03-03 View
510(k) K151529 Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone CalibratorCDZ2016-02-11 View

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