510(k) K190109 ยท JWY Manual Antimicrobial Susceptibility Test Systems
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
| Applicant | Beckman Coulter, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Apr 18, 2019 |
| Received | Jan 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190109
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.