Medical Device Manufacturer · US , New York , NY

Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices

152 submissions · 151 cleared · Since 2008
152
Total
151
Cleared
1
Denied
152 devices
76-100 of 152
Cleared Jan 27, 2015
ADVIA Centaur IgE Master Curve Material
K143680 · JJX
Immunology · 34d
Cleared Jan 14, 2015
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000...
K143504 · JJX
Chemistry · 35d
Cleared Dec 24, 2014
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000...
K143352 · JJX
Immunology · 30d
Cleared Dec 23, 2014
ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur...
K143376 · JJX
Immunology · 28d
Cleared Dec 05, 2014
ADVIA Centaur HAV total assay
K142758 · LOL
Microbiology · 71d
Cleared Dec 05, 2014
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol...
K143194 · JJX
Chemistry · 29d
Cleared Nov 26, 2014
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI...
K140842 · CEC
Chemistry · 238d
Cleared Nov 26, 2014
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA...
K140859 · CEC
Chemistry · 237d
Cleared Oct 30, 2014
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material,...
K142878 · JJX
Chemistry · 28d
Cleared Oct 29, 2014
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free...
K142811 · JJX
Chemistry · 30d
Cleared Oct 29, 2014
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur...
K142864 · JJX
Chemistry · 28d
Cleared Aug 19, 2014
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
K141772 · JJX
Microbiology · 49d
Cleared Jul 24, 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
K133156 · MRG
Chemistry · 280d
Cleared Jul 09, 2014
IMMULITE 2000
K141444 · JJX
Chemistry · 37d
Cleared Jun 24, 2014
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
K133816 · JJX
Immunology · 190d
Cleared May 28, 2014
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
K132801 · DHB
Immunology · 257d
Cleared May 01, 2014
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I...
K140818 · JJX
Chemistry · 30d
Cleared Apr 01, 2014
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION...
K140541 · JJX
Chemistry · 28d
Cleared Mar 31, 2014
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE...
K140505 · JJX
Chemistry · 32d
Cleared Mar 10, 2014
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN...
K140267 · JJX
Chemistry · 35d
Cleared Mar 05, 2014
IMMULITE 2000 DHEA-SO4
K140258 · JJX
Chemistry · 30d
Cleared Feb 21, 2014
ADVIA CENTAUR TESTOSTERONE (TSTO)
K133491 · CDZ
Chemistry · 100d
Cleared Feb 05, 2014
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
K133601 · CEW
Chemistry · 72d
Cleared Jan 27, 2014
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K132638 · CGX
Chemistry · 157d
Cleared Jan 24, 2014
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
K131307 · LCP
Chemistry · 262d

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