510(k) K191638 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
| Applicant | Medtest DX, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Mar 12, 2020 |
| Received | Jun 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191638
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.