510(k) K923212 ยท JWX Kit, Screening, Staphylococcus Aureus
SLIDEX STAPH-KIT
| Applicant | Biomerieux Vitek, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Sep 28, 1992 |
| Received | Jul 1, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2012 | bioMerieux, Inc. SLIDEX Staph kit (250 Tests).
The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media. Terminated |
JWX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.