510(k) K973075 ยท DKZ Enzyme Immunoassay, Amphetamine
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Oct 9, 1997 |
| Received | Aug 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973075
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.