Biomerieux Vitek, Inc. - FDA 510(k) Cleared Devices
49
Total
49
Cleared
0
Denied
49 devices
Cleared
Sep 15, 1993
BIOMERIEUX HEMOLAB COFAC VIII
Hematology
86d
Cleared
Sep 10, 1993
VIDAS DIGOXIN (DIG)
General & Plastic Surgery
123d
Cleared
Aug 16, 1993
VIDAS THEOPHYLLINE(THEO)
Toxicology
41d
Cleared
Aug 09, 1993
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
Microbiology
370d
Cleared
Jul 27, 1993
VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT
Chemistry
148d
Cleared
Jun 21, 1993
VIDAS TOXO COMPETITION (TXC) ASSAY
Microbiology
97d
Cleared
May 20, 1993
VIDAS TOTAL IGE (IGE) ASSAY
Immunology
71d
Cleared
May 18, 1993
BIOMERIEUX HEMOLAB FIBRINOMAT
Hematology
197d
Cleared
May 13, 1993
VIDAS THYROXINE (T4) ASSAY (T4)
Chemistry
143d
Cleared
May 11, 1993
VIDAS TOXO IG6 ASSAY (TX6)
Microbiology
337d
Cleared
Mar 23, 1993
VITEK RAPID CALL-GRAM NEGATIV IDENT CARD
Microbiology
120d
Cleared
Mar 23, 1993
VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD
Chemistry
120d
Cleared
Feb 25, 1993
VIDAS TOXOPLASMA GONDII IGM ASSSAY
Microbiology
241d
Cleared
Feb 12, 1993
MINIVIDAS INSTRUMENT
Chemistry
207d
Cleared
Feb 12, 1993
VIDAS ESTRADIOL (E2) ASSAY
Chemistry
105d
Cleared
Feb 03, 1993
BAC-T-SCREEN
Microbiology
167d
Cleared
Feb 03, 1993
BIOMERIEUX HEMOLAB THROMBOMAT
Hematology
93d
Cleared
Nov 30, 1992
VIDAS FREE THYROXINE(FT4) ASSAY
Chemistry
47d
Cleared
Oct 26, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
Microbiology
122d
Cleared
Oct 14, 1992
RAPID NFT, MODIFICATION
Microbiology
128d
Cleared
Sep 28, 1992
SLIDEX STAPH-KIT
Microbiology
89d
Cleared
Sep 25, 1992
HEMOLAB SILIMAT REAGENT
Hematology
267d
Cleared
Jun 18, 1992
VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY
Chemistry
64d
Cleared
Jun 16, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
Chemistry
64d