510(k) K192943 ยท DJG Enzyme Immunoassay, Opiates
CEDIA Heroin Metabolite (6-AM) assay
| Applicant | Microgenics Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Dec 16, 2019 |
| Received | Oct 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192943
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.