# Vitek Systems, Inc.

- Location (FDA's records): Hazelwood, MI
- FDA decisions: 39 (1978–1993): 39 510(k) clearances
- Product codes: JTO (4), JSP (3), JSS (3), CEP (2), DLJ (2), JXB (2), LJC (2), JHI (1), DIY (1), DBF (1), LFX (1), GTJ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- bioMerieux, Inc.: 2 (https://510kreport.com/company/biomerieux)
- Bio-Rad Laboratories, Inc.: 2 (https://510kreport.com/company/bio-rad-laboratories)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)

## Its most-cited devices
- K920661: Vidas CMV Igg Assay (1993), cited by 3
- K891385: Vitek Immunodiagnostic Assay System (Vidas) (1989), cited by 2
- K921302: Vitek Immunodiagnostic Assay System (1992), cited by 1
- K902925: Vitek Immunodiagnostic Assay System (Vidas) (RBG) (1990), cited by 1
- K910304: Rapid Coryne Syst/Identif of Coryneform Bacteria (1991), cited by 1

## Recent decisions
- K920661: Vidas CMV Igg Assay (Feb 12, 1993)
- K921302: Vitek Immunodiagnostic Assay System (Jul 28, 1992)
- K921176: Vitek Immunodiagnostic Assay System (Apr 8, 1992)
- K920952: Vitek Immunodiag Assay Syst (Vidas) Ferritine Assay (Apr 7, 1992)
- K915884: Vidas Chlamydia Assay, Modification (Mar 4, 1992)
- K905211: Vidas Clostridium Difficile Toxin a (Cda) Assay (Oct 11, 1991)
- K912371: Biomerieux RSV Direct IF Kit (Sep 23, 1991)
- K910230: Lyme-Spot IF Kit (Aug 30, 1991)

Source page: https://510kreport.com/company/vitek-systems