510(k) K193024 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae 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, Jan 8, 2020 |
| Received | Oct 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193024
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.