510(k) K103161 ยท DJG Enzyme Immunoassay, Opiates
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES
| Applicant | Omega Laboratories, Inc., Mogadore OH, US |
| Decision | Substantially Equivalent, Dec 13, 2011 |
| Received | Oct 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103161
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.