510(k) K112808 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
| Applicant | Omega Laboratories, Inc., Mogadore OH, US |
| Decision | Substantially Equivalent, Jan 23, 2012 |
| Received | Sep 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112808
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.