510(k) K190968 ยท JXM Enzyme Immunoassay, Benzodiazepine
CEDIA Benzodiazepine Assay
| Applicant | Microgenics Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Dec 9, 2019 |
| Received | Apr 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190968
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.