510(k) K895043 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
COMA COCAINE METABOLITE ASSAY (EIA)
| Applicant | Serex, Inc., Tenafly NJ, US |
| Decision | Substantially Equivalent, Nov 8, 1989 |
| Received | Aug 9, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895043
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.