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
95 devices
51-75 of 95
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 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 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
Cleared Jan 24, 2014
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K133728 · CGX
Chemistry · 49d
Cleared Nov 22, 2013
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
K133067 · CDT
Chemistry · 56d
Cleared Oct 25, 2013
IMMULITE 2000
K133124 · JJX
Chemistry · 25d
Cleared Oct 22, 2013
IMMULITE 2000
K133128 · JJX
Chemistry · 22d
Cleared Oct 16, 2013
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP...
K132664 · CJW
Chemistry · 50d
Cleared Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
K131662 · JJX
Chemistry · 125d
Cleared Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
K132249 · CEC
Chemistry · 56d
Cleared Mar 22, 2013
DIMENSION EXL WITH LM SYSTEM
K130276 · JJE
Chemistry · 45d
Cleared Dec 20, 2012
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
K123046 · DFC
Chemistry · 83d

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