510(k) K142855 ยท DKZ Enzyme Immunoassay, Amphetamine
Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)
| Applicant | Omega Laboratories, Inc., Mogadore OH, US |
| Decision | Substantially Equivalent, Jul 28, 2015 |
| Received | Sep 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142855
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.