510(k) K080436 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
| Applicant | Quantrx Biomedical Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Feb 11, 2009 |
| Received | Feb 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080436
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.