510(k) K181368 · NGZ Susceptibility Test Plate, Antifungal
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jun 20, 2018 |
| Received | May 23, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181368
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.