510(k) K181946 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Aug 8, 2018 |
| Received | Jul 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181946
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.