510(k) K232310 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Oct 31, 2023 |
| Received | Aug 2, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232310
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.