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Vitek Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
39
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K920661VIDAS CMV IGG ASSAYFebruary 12, 1993
K921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMJuly 28, 1992
K921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMApril 8, 1992
K920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYApril 7, 1992
K915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONMarch 4, 1992
K905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAYOctober 11, 1991
K912371BIOMERIEUX RSV DIRECT IF KITSeptember 23, 1991
K910230LYME-SPOT IF KITAugust 30, 1991
K910210SLIDEX MENINGITE-KIT 5August 12, 1991
K910304RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIAJuly 26, 1991
K911429VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIEDJune 24, 1991
K910499IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUSMay 1, 1991
K905787VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYSTApril 29, 1991
K910666VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATIONApril 3, 1991
K895805SLIDEX ROTA-KIT 2February 26, 1991
K905020SLIDEX STREPTO-KITJanuary 28, 1991
K902925VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)August 9, 1990
K900996VITEK ANAEROBE IDENTIFICATION CARDMay 11, 1990
K900818VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.April 30, 1990
K896097VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAYFebruary 26, 1990