Vitek Systems, Inc. - FDA 510(k) Cleared Devices
39
Total
39
Cleared
0
Denied
FDA 510(k) Regulatory Record - Vitek Systems, Inc. Microbiology ✕
27 devices
Cleared
Feb 12, 1993
VIDAS CMV IGG ASSAY
Microbiology
365d
Cleared
Mar 04, 1992
VIDAS CHLAMYDIA ASSAY, MODIFICATION
Microbiology
83d
Cleared
Oct 11, 1991
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
Microbiology
325d
Cleared
Sep 23, 1991
BIOMERIEUX RSV DIRECT IF KIT
Microbiology
117d
Cleared
Aug 30, 1991
LYME-SPOT IF KIT
Microbiology
224d
Cleared
Aug 12, 1991
SLIDEX MENINGITE-KIT 5
Microbiology
209d
Cleared
Jul 26, 1991
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
Microbiology
183d
Cleared
Jun 24, 1991
VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
Microbiology
90d
Cleared
May 01, 1991
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
Microbiology
85d
Cleared
Apr 29, 1991
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST
Microbiology
123d
Cleared
Apr 03, 1991
VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
Microbiology
51d
Cleared
Feb 26, 1991
SLIDEX ROTA-KIT 2
Microbiology
516d