510(k) K192729 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Nov 6, 2019 |
| Received | Sep 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192729
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.