510(k) K152232 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Quest Diagnostics HairCheck-DT (Cocaine)
| Applicant | Quest Diagnostics Incorporated, Lenexa KS, US |
| Decision | Substantially Equivalent, Nov 18, 2016 |
| Received | Aug 7, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152232
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.