510(k) K183324 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Feb 15, 2019 |
| Received | Nov 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183324
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.