510(k) K113751 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
RANDOX COCAINE METABOLITE
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, May 8, 2012 |
| Received | Dec 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113751
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.