510(k) K012396 ยท DKZ Enzyme Immunoassay, Amphetamine
ONTRAK TESTCARD 9
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 5, 2001 |
| Received | Jul 27, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K012396
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.