510(k) K994165 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 7, 2000 |
| Received | Dec 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994165
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.