FDA applicant

Vitek Systems, Inc.

Hazelwood, MI39 decisions1978–19934 recalls

FDA records 39 decisions for Vitek Systems, Inc. (Hazelwood, MI) from 1978 to 1993: 39 510(k) clearances. Most are in product codes JTO (Discs, Strips And Reagents, Microorganism…) and JSP (Kit, Anaerobic Identification). 4 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 Vitek Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2022

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Vitek”

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

Vitek, Inc. 1

Vitek Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Vitek”