510(k) K921834 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
AUTOMATES COMA COCAINE METABOLITE ASSAY
| Applicant | Serex, Inc., Maywood NJ, US |
| Decision | Substantially Equivalent, Jun 15, 1992 |
| Received | Apr 16, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921834
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.