Siemens Healthcare Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL), ADVIA 2120i, ADVIA 2120, LOCI Total Vitamin D Total Assay, LOCI VITD CAL
92
Total
92
Cleared
0
Denied
FDA 510(k) Regulatory Record - Siemens Healthcare Diagnostics Hematology ✕
11 devices
Cleared
Aug 11, 2017
ADVIA 2120i, ADVIA 2120
Hematology
289d
Cleared
Sep 30, 2016
Xprecia Stride Coagulation System, Xprecia System PT Controls
Hematology
442d
Cleared
Nov 23, 2011
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
Hematology
435d
Cleared
May 16, 2011
STRATUS CS ACUTE CARE D-DIMER
Hematology
104d
Cleared
Nov 29, 2010
INNOVANCE D-DIMER, MODEL OPBP09
Hematology
370d
Cleared
Jul 28, 2010
ADVIA 2120/2120I BODY FLUIDS
Hematology
532d
Cleared
Oct 29, 2009
INNOVANCE D-DIMER, MODEL OPBP09
Hematology
121d
Cleared
May 28, 2009
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
Hematology
339d
Cleared
Jan 26, 2009
BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND...
Hematology
91d
Cleared
Jan 26, 2009
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND...
Hematology
90d
Cleared
Oct 24, 2008
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
Hematology
127d