510(k) K133817 ยท NGZ Susceptibility Test Plate, Antifungal
VITEK 2 AST - YEAST FLUCONAZOLE
| Applicant | bioMerieux, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Aug 5, 2014 |
| Received | Dec 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133817
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.