510(k) Report

FDA applicant

Biomerieux Vitek, Inc.

Hazelwood, MO50 decisions1978–199813 recalls

FDA records 50 decisions for Biomerieux Vitek, Inc. (Hazelwood, MO) from 1978 to 1998: 49 510(k) clearances and 1 original PMA approval. Most are in product codes GJT (Plasma, Coagulation Factor Deficient) and LGD (Enzyme Linked Immunoabsorbent Assay…). Its devices cite 1 predicate, 0 of them its own earlier devices. 13 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Biomerieux Vitek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biomerieux Vitek, Inc. since 2007.

Recalls per year

3in 2022

2011: 12017: 32018: 32019: 12021: 12022: 3
2007high 3 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Biomerieux Vitek, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GJTPlasma, Coagulation Factor Deficient5decisions
  • LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii3decisions
  • LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus2decisions
  • LQLGram Positive Identification Panel2decisions
  • CHPRadioimmunoassay, Estradiol2decisions
  • LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)1decision

Also: GHH (1), JXA (1), JWX (1), JLW (1), DAP (1), KFF (1).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K923166Vidas Toxoplasma Gondii Igm AsssayBiomerieux Vitek, Inc. · 19936cite it
  • K973819Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 19982cite it
  • K933549Vidas CMV Igm AssayBiomerieux Vitek, Inc. · 19942cite it
  • K924218Bac-T-ScreenBiomerieux Vitek, Inc. · 19931cites it
  • K922737Vidas Toxo IG6 Assay (TX6)Biomerieux Vitek, Inc. · 19931cites it
  • K921816Vitek Immun Assay Sys (Vidas) Thyroi Stim Hor AssayBiomerieux Vitek, Inc. · 19921cites it

What has FDA decided for it lately?

  • K973819Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
  • K972895Vidas Rotavirus (RTV) AssayBiomerieux Vitek, Inc. · 1997
  • K965092Vidas Rotavirus AssayBiomerieux Vitek, Inc. · 1997
  • K964887Vidas C. Difficile Toxin a II AssayBiomerieux Vitek, Inc. · 1997
  • K955627Vidas Chlamydia Blocking AssayBiomerieux Vitek, Inc. · 1996
  • K962549Vidas Creatine Kinase MB Assay 30-421Biomerieux Vitek, Inc. · 1996
  • K962609Gram Negative Identification Plus CardBiomerieux Vitek, Inc. · 1996
  • K952095Vitek Gram Positive Identification Card (Gpi)Biomerieux Vitek, Inc. · 19962 recalls

All 50 as Biomerieux Vitek, Inc. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K923122Vidas Clinicalvidas Varicel. Zoster Igg 60 T, Catalog 30217Nov 9, 2022Class II
  • K955647Vidas Clinical Vidas Estradiol II 60 Tests, Catalog 30431-01Nov 9, 2022Class II
  • K933549VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.Feb 9, 2022Class II
  • K933549VIDAS¿ CMV IgM 30 TestsMar 16, 2021Class II
  • K923122VIDAS Varicella Zoster IgG (VZG) antibody IVD, kitDec 10, 2019Class II
  • K921746VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France.…Apr 9, 2018Class II

Other applicant names beginning “Biomerieux”

FDA records each applicant name separately; these may or may not be the same firm.

bioMerieux, Inc. 283