510(k) K151817 ยท NGZ Susceptibility Test Plate, Antifungal
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Feb 18, 2016 |
| Received | Jul 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151817
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.