510(k) K103227 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
ORATECT ORAL FLUID DRUG SCREEN DEVICES
| Applicant | Branan Medical Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 11, 2012 |
| Received | Nov 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103227
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.