510(k) K981388 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
MICRO-STRIP FOR COCAINE METABOLITES
| Applicant | Microdiagnostics, Inc., Laguna Niguel CA, US |
| Decision | Substantially Equivalent, May 29, 1998 |
| Received | Apr 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981388
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.