510(k) K093664 ยท DKZ Enzyme Immunoassay, Amphetamine
AMPHETAMINES II ASSAY
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 28, 2010 |
| Received | Nov 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093664
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.