510(k) K232963 · NGZ Susceptibility Test Plate, Antifungal
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jun 7, 2024 |
| Received | Sep 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232963
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.