510(k) K150925 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, Jun 29, 2015 |
| Received | Apr 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150925
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.