510(k) K243738 · NGZ Susceptibility Test Plate, Antifungal
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Feb 27, 2025 |
| Received | Dec 4, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243738
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.