Medical Device Manufacturer · US , Hazelwood , MO

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

49 submissions · 49 cleared · Since 1992
49
Total
49
Cleared
0
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.

49 devices
1–12 of 49
VIDAS D-DIMER (DD) ASSAY
K973819 · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control · Hematology
Mar 1998 154d
VIDAS ROTAVIRUS (RTV) ASSAY
K972895 · LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus · Microbiology
Oct 1997 59d
VIDAS ROTAVIRUS ASSAY
K965092 · LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus · Microbiology
May 1997 137d
VIDAS C. DIFFICILE TOXIN A II ASSAY
K964887 · LLH Reagents, Clostridium Difficile Toxin · Microbiology
Apr 1997 123d
VIDAS CHLAMYDIA BLOCKING ASSAY
K955627 · LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · Microbiology
Oct 1996 301d
VIDAS CREATINE KINASE MB ASSAY 30-421
K962549 · JHX Fluorometric Method, Cpk Or Isoenzymes · Chemistry
Aug 1996 63d
GRAM NEGATIVE IDENTIFICATION PLUS CARD
K962609 · LRH Instrument For Auto Reader Of Overnight Microorganism Identification System · Microbiology
Aug 1996 58d
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
K952095 · LQL Gram Positive Identification Panel · Microbiology
Mar 1996 313d
VIDAS ESTRADIOL II (E2II) ASSAY
K955647 · CHP Radioimmunoassay, Estradiol · Chemistry
Feb 1996 56d
VIDAS LYME SCREEN II
K943812 · LSR Reagent, Borrelia Serological Reagent · Microbiology
Jun 1995 312d
BIOMERIEUX HEMOLAB COFAC II
K942049 · GJT Plasma, Coagulation Factor Deficient · Hematology
May 1995 386d
HEMOLAB COFAC IX
K942050 · GJT Plasma, Coagulation Factor Deficient · Hematology
May 1995 386d

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All49 Microbiology 18 Hematology 15 Chemistry 13 Toxicology 1 Immunology 1 General & Plastic Surgery 1