510(k) K083764 ยท DKZ Enzyme Immunoassay, Amphetamine
AMPHETAMINES II
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 3, 2010 |
| Received | Dec 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083764
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.