Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices
152
Total
151
Cleared
1
Denied
152 devices
Cleared
Jan 27, 2015
ADVIA Centaur IgE Master Curve Material
Immunology
34d
Cleared
Jan 14, 2015
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000...
Chemistry
35d
Cleared
Dec 24, 2014
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000...
Immunology
30d
Cleared
Dec 23, 2014
ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur...
Immunology
28d
Cleared
Dec 05, 2014
ADVIA Centaur HAV total assay
Microbiology
71d
Cleared
Dec 05, 2014
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol...
Chemistry
29d
Cleared
Nov 26, 2014
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI...
Chemistry
238d
Cleared
Nov 26, 2014
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA...
Chemistry
237d
Cleared
Oct 30, 2014
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material,...
Chemistry
28d
Cleared
Oct 29, 2014
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free...
Chemistry
30d
Cleared
Oct 29, 2014
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur...
Chemistry
28d
Cleared
Aug 19, 2014
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
Microbiology
49d
Cleared
Jul 24, 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
Chemistry
280d
Cleared
Jul 09, 2014
IMMULITE 2000
Chemistry
37d
Cleared
Jun 24, 2014
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
Immunology
190d
Cleared
May 28, 2014
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
Immunology
257d
Cleared
May 01, 2014
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I...
Chemistry
30d
Cleared
Apr 01, 2014
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION...
Chemistry
28d
Cleared
Mar 31, 2014
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE...
Chemistry
32d
Cleared
Mar 10, 2014
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN...
Chemistry
35d
Cleared
Mar 05, 2014
IMMULITE 2000 DHEA-SO4
Chemistry
30d
Cleared
Feb 21, 2014
ADVIA CENTAUR TESTOSTERONE (TSTO)
Chemistry
100d
Cleared
Feb 05, 2014
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
Chemistry
72d
Cleared
Jan 27, 2014
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
Chemistry
157d
Cleared
Jan 24, 2014
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
Chemistry
262d
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