Biomerieux Vitek, Inc. - FDA 510(k) Cleared Devices

Cleared Oct 03, 1997

VIDAS ROTAVIRUS (RTV) ASSAY

K972895 · LIQ

Microbiology · 59d

Cleared May 05, 1997

VIDAS ROTAVIRUS ASSAY

K965092 · LIQ

Microbiology · 137d

Cleared Apr 08, 1997

VIDAS C. DIFFICILE TOXIN A II ASSAY

K964887 · LLH

Microbiology · 123d

Cleared Oct 07, 1996

VIDAS CHLAMYDIA BLOCKING ASSAY

K955627 · LJC

Microbiology · 301d

Cleared Aug 30, 1996

GRAM NEGATIVE IDENTIFICATION PLUS CARD

K962609 · LRH

Microbiology · 58d

Cleared Mar 12, 1996

VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)

K952095 · LQL

Microbiology · 313d

Cleared Jun 13, 1995

VIDAS LYME SCREEN II

K943812 · LSR

Microbiology · 312d

Cleared Dec 22, 1994

BIOMERIEUX HEMOLAB AT III

K934156 · JBQ

Microbiology · 482d

Cleared Aug 02, 1994

VIDAS CMV IGM ASSAY

K933549 · LKQ

Microbiology · 376d

Cleared Aug 09, 1993

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA

K923903 · LJY

Microbiology · 370d

Cleared Jun 21, 1993

VIDAS TOXO COMPETITION (TXC) ASSAY

K931334 · LGD

Microbiology · 97d

Cleared May 11, 1993

VIDAS TOXO IG6 ASSAY (TX6)

K922737 · LGD

Microbiology · 337d

Cleared Mar 23, 1993

VITEK RAPID CALL-GRAM NEGATIV IDENT CARD

K925915 · LQM

Microbiology · 120d

Cleared Feb 25, 1993

VIDAS TOXOPLASMA GONDII IGM ASSSAY

K923166 · LGD

Microbiology · 241d

Cleared Feb 03, 1993

BAC-T-SCREEN

K924218 · JXA

Microbiology · 167d

Cleared Oct 26, 1992

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

K923122 · LFY

Microbiology · 122d

Cleared Oct 14, 1992

RAPID NFT, MODIFICATION

K922768 · JSW

Microbiology · 128d

Cleared Sep 28, 1992

SLIDEX STAPH-KIT

K923212 · JWX

Microbiology · 89d