510(k) K173195 ยท DJG Enzyme Immunoassay, Opiates
DRI Hydrocodone Assay
| Applicant | Microgenics Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Feb 13, 2018 |
| Received | Oct 2, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173195
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.