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Biomerieux Vitek, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
49
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K973819VIDAS D-DIMER (DD) ASSAYMarch 10, 1998
K972895VIDAS ROTAVIRUS (RTV) ASSAYOctober 3, 1997
K965092VIDAS ROTAVIRUS ASSAYMay 5, 1997
K964887VIDAS C. DIFFICILE TOXIN A II ASSAYApril 8, 1997
K955627VIDAS CHLAMYDIA BLOCKING ASSAYOctober 7, 1996
K962549VIDAS CREATINE KINASE MB ASSAY 30-421August 30, 1996
K962609GRAM NEGATIVE IDENTIFICATION PLUS CARDAugust 30, 1996
K952095VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)March 12, 1996
K955647VIDAS ESTRADIOL II (E2II) ASSAYFebruary 6, 1996
K943812VIDAS LYME SCREEN IIJune 13, 1995
K942050HEMOLAB COFAC IXMay 19, 1995
K942049BIOMERIEUX HEMOLAB COFAC IIMay 19, 1995
K935850BIOMERIEUX HEMOLAB COFAC VIIJanuary 17, 1995
K935851BIOMERIEUX HEMOLAB COFAC XJanuary 17, 1995
K931992HEMOLABDecember 22, 1994
K934210HEMOLAB PROTEIN C CHROMOGENIC ASSAYDecember 22, 1994
K934156BIOMERIEUX HEMOLAB AT IIIDecember 22, 1994
K943811ENZYME-LINKED FLUORESCENT IMMUNOASSAYNovember 2, 1994
K933549VIDAS CMV IGM ASSAYAugust 2, 1994
K934274HEMOLAB HEPARICHROM ASSAYMay 6, 1994