510(k) K140671 ยท DJG Enzyme Immunoassay, Opiates
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE
| Applicant | Omega Laboratories, Inc., Mogadore OH, US |
| Decision | Substantially Equivalent, Jan 8, 2015 |
| Received | Mar 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140671
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.