510(k) K173963 ยท JXM Enzyme Immunoassay, Benzodiazepine
DRI Benzodiazepine Assay
| Applicant | Microgenics Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Feb 21, 2018 |
| Received | Dec 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173963
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.