510(k) K092275 ยท DKZ Enzyme Immunoassay, Amphetamine
RANDOX ECSTASY (MDMA) ASSAY
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Mar 1, 2011 |
| Received | Jul 28, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092275
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.