510(k) K192250 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Oct 16, 2019 |
| Received | Aug 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192250
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.