510(k) K221765 ยท JXM Enzyme Immunoassay, Benzodiazepine
ONLINE DAT Benzodiazepines II
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 23, 2022 |
| Received | Jun 17, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221765
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.