510(k) K172274 · JWY Manual Antimicrobial Susceptibility Test Systems
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Aug 30, 2017 |
| Received | Jul 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172274
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.