510(k) K910278 ยท DKZ Enzyme Immunoassay, Amphetamine
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Apr 3, 1991 |
| Received | Jan 23, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910278
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.