510(k) K041144 ยท DJG Enzyme Immunoassay, Opiates
RANDOX OPIATES ASSAY
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Nov 3, 2004 |
| Received | Apr 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041144
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.