510(k) K092258 ยท DJR Enzyme Immunoassay, Methadone
RANDOX METABOLITE (EDDP) ASSAY
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Nov 9, 2010 |
| Received | Jul 28, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092258
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.