510(k) K043028 ยท DKZ Enzyme Immunoassay, Amphetamine
EMIT II PLUS ECSTASY ASSAY
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 7, 2005 |
| Received | Nov 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043028
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.