510(k) K230935 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Jun 30, 2023 |
| Received | Apr 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230935
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.