510(k) K030360 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
RANDOX EVIDENCE
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Dec 23, 2003 |
| Received | Feb 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030360
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.