510(k) K242843 ยท JWY Manual Antimicrobial Susceptibility Test Systems
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Jun 20, 2025 |
| Received | Sep 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242843
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.