510(k) K101160 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
ROCHE ORAL FLUID COCAINE
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 11, 2011 |
| Received | Apr 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101160
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.