510(k) K170293 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Emit II Plus Cocaine Metabolite Assay
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Oct 25, 2017 |
| Received | Jan 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170293
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.