510(k) K202612 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Jul 23, 2021 |
| Received | Sep 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202612
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.