510(k) K250575 ยท JWY Manual Antimicrobial Susceptibility Test Systems
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Sep 5, 2025 |
| Received | Feb 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250575
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.