510(k) K001417 ยท DKZ Enzyme Immunoassay, Amphetamine
ONTRAK TESTCUP 502, MODEL 3016641
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 29, 2000 |
| Received | May 5, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001417
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.