510(k) K223844 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Mar 21, 2023 |
| Received | Dec 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223844
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.