510(k) K040350 ยท DKZ Enzyme Immunoassay, Amphetamine
RANDOX AMPHETAMINE CLASS ASSAY
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, May 12, 2004 |
| Received | Feb 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040350
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.