510(k) K242021 ยท JWY Manual Antimicrobial Susceptibility Test Systems
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Oct 9, 2024 |
| Received | Jul 11, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242021
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.