510(k) DEN190016 ยท QIV Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
cobas vivoDx MRSA
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Unknown, Dec 5, 2019 |
| Received | Mar 19, 2019 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN190016
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.