510(k) K243201 ยท JWY Manual Antimicrobial Susceptibility Test Systems
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Feb 10, 2025 |
| Received | Oct 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243201
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.