510(k) K061945 ยท NGZ Susceptibility Test Plate, Antifungal
VITEK 2 AST-YS FLUCONAZOLE
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Sep 19, 2006 |
| Received | Jul 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061945
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.