510(k) K182797 · JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Nov 30, 2018 |
| Received | Oct 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182797
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.