510(k) K211973 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DRI Cocaine Metabolite Assay
| Applicant | Microgenics Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Sep 24, 2021 |
| Received | Jun 25, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211973
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.