Biomerieux Vitek, Inc. - FDA 510(k) Cleared Devices
49
Total
49
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biomerieux Vitek, Inc. Hematology ✕
15 devices
Cleared
Mar 10, 1998
VIDAS D-DIMER (DD) ASSAY
Hematology
154d
Cleared
May 19, 1995
BIOMERIEUX HEMOLAB COFAC II
Hematology
386d
Cleared
May 19, 1995
HEMOLAB COFAC IX
Hematology
386d
Cleared
Jan 17, 1995
BIOMERIEUX HEMOLAB COFAC VII
Hematology
405d
Cleared
Jan 17, 1995
BIOMERIEUX HEMOLAB COFAC X
Hematology
405d
Cleared
Dec 22, 1994
HEMOLAB
Hematology
608d
Cleared
Dec 22, 1994
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
Hematology
479d
Cleared
May 06, 1994
HEMOLAB HEPARICHROM ASSAY
Hematology
248d
Cleared
Apr 21, 1994
BIOMERIEUX HEMOLAB THROMBICALCI-TEST
Hematology
535d
Cleared
Mar 22, 1994
BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL
Hematology
427d
Cleared
Nov 03, 1993
FDP - SLIDEX DIRECT
Hematology
554d
Cleared
Sep 15, 1993
BIOMERIEUX HEMOLAB COFAC VIII
Hematology
86d
Cleared
May 18, 1993
BIOMERIEUX HEMOLAB FIBRINOMAT
Hematology
197d
Cleared
Feb 03, 1993
BIOMERIEUX HEMOLAB THROMBOMAT
Hematology
93d
Cleared
Sep 25, 1992
HEMOLAB SILIMAT REAGENT
Hematology
267d