510(k) K192355 ยท JWY Manual Antimicrobial Susceptibility Test Systems
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
| Applicant | Beckman Coulter, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Nov 14, 2019 |
| Received | Aug 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192355
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.