510(k) K240445 ยท JWY Manual Antimicrobial Susceptibility Test Systems
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, May 16, 2024 |
| Received | Feb 15, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240445
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.