510(k) K935016 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
COCAINE METABOLITE EIA ASSAY MODIFICATION
| Applicant | Diagnostic Reagents, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Dec 3, 1993 |
| Received | Oct 18, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935016
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.