510(k) K990418 ยท DKZ Enzyme Immunoassay, Amphetamine
ONTRAK TESTCUP-ER M2K
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 13, 1999 |
| Received | Feb 10, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990418
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.