Siemens Healthcare Diagnostics - FDA 510(k) Cleared Devices
92
Total
92
Cleared
0
Denied
92 devices
Cleared
Sep 21, 2011
CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
Chemistry
254d
Cleared
Aug 25, 2011
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
Chemistry
143d
Cleared
Aug 15, 2011
RAPIDPOINT 405 NEONATAL BILIRUBIN
Chemistry
196d
Cleared
Aug 01, 2011
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Immunology
423d
Cleared
May 16, 2011
STRATUS CS ACUTE CARE D-DIMER
Hematology
104d
Cleared
May 13, 2011
DIMENSIONS HB1C KIT, MODEL DF105A
Chemistry
259d
Cleared
Apr 28, 2011
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
Chemistry
132d
Cleared
Apr 18, 2011
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7...
Immunology
437d
Cleared
Apr 12, 2011
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI...
Immunology
432d
Cleared
Apr 07, 2011
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
Chemistry
77d
Cleared
Mar 07, 2011
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
Chemistry
249d
Cleared
Nov 29, 2010
INNOVANCE D-DIMER, MODEL OPBP09
Hematology
370d
Cleared
Nov 23, 2010
ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
Chemistry
53d
Cleared
Sep 30, 2010
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Immunology
364d
Cleared
Sep 10, 2010
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
Microbiology
113d
Cleared
Aug 02, 2010
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
Toxicology
189d
Cleared
Jul 28, 2010
ADVIA 2120/2120I BODY FLUIDS
Hematology
532d
Cleared
Jul 09, 2010
LOCI 8 CALIBRATOR, MODEL KC 646
Chemistry
44d
Cleared
May 19, 2010
ADVIA CHEMISTRY SALICYLATE REAGENT
Chemistry
148d
Cleared
May 13, 2010
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM...
Microbiology
86d
Cleared
May 10, 2010
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF...
Chemistry
97d
Cleared
May 05, 2010
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
Chemistry
47d
Cleared
Apr 07, 2010
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
Chemistry
153d
Cleared
Mar 22, 2010
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
Chemistry
108d
Cleared
Mar 05, 2010
EXL ANEM CAL, MODEL RC640
Chemistry
100d
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