Dade Behring, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PT-MULTI-CALIBRATOR, MODEL OPAT07, DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST, DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
343
Total
343
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dade Behring, Inc. Hematology ✕
46 devices
Cleared
Dec 20, 2010
PT-MULTI-CALIBRATOR, MODEL OPAT07
Hematology
369d
Cleared
Sep 19, 2007
FIBRINOGEN CALIBRATOR KIT
Hematology
33d
Cleared
Mar 23, 2007
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
Hematology
136d
Cleared
Jul 21, 2006
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
Hematology
147d
Cleared
Aug 17, 2005
STRATUS CS D-DIMER
Hematology
62d
Cleared
Jun 29, 2005
DADE THROMBIN REAGENT
Hematology
76d
Cleared
Dec 10, 2004
ENZYGNOST F+2 (MONOCLONAL) TEST KIT
Hematology
72d
Cleared
Dec 02, 2004
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
Hematology
38d
Cleared
Dec 01, 2004
CONTROL PLASMA N, PROC CONTROL PLASMA
Hematology
93d
Cleared
Oct 21, 2004
CONTROL PLASMA N AND CONTROL PLASMA P
Hematology
66d
Cleared
Aug 11, 2004
ADVANCED D-DIMER ASSAY
Hematology
71d
Cleared
Sep 08, 2003
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540....
Hematology
130d
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