Medical Device Manufacturer · US , Hazelwood , MO

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

49 submissions · 49 cleared · Since 1992

Total

Cleared

Denied

Biomerieux Vitek, Inc. has 49 FDA 510(k) cleared medical devices. Based in Hazelwood, US.

Historical record: 49 cleared submissions from 1992 to 1998.

Browse the FDA 510(k) cleared devices submitted by Biomerieux Vitek, Inc. Filter by specialty or product code using the sidebar.

Biomerieux Vitek, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Biomerieux Vitek, Inc.

49 devices

1-12 of 49

Cleared Mar 10, 1998

VIDAS D-DIMER (DD) ASSAY

K973819 · DAP

Hematology · 154d

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

VIDAS CREATINE KINASE MB ASSAY 30-421

K962549 · JHX

Chemistry · 63d

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 Feb 06, 1996

VIDAS ESTRADIOL II (E2II) ASSAY

BIOMERIEUX HEMOLAB COFAC II

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

FDA 510(k) Regulatory Record - Biomerieux Vitek, Inc.

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