510(k) K150502 ยท DJG Enzyme Immunoassay, Opiates
DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
| Applicant | Microgenics Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Oct 9, 2015 |
| Received | Feb 26, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150502
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.