510(k) K113747 ยท DJG Enzyme Immunoassay, Opiates
RANDOX OPIATES ASSAY
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Aug 24, 2012 |
| Received | Dec 20, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113747
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.