510(k) K050394 ยท DKZ Enzyme Immunoassay, Amphetamine
SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS
| Applicant | Medtox Diagnostics, Inc., Burlington NC, US |
| Decision | Substantially Equivalent, Oct 25, 2005 |
| Received | Feb 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050394
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.