510(k) K881817 ยท DJP Radioimmunoassay, Amphetamine
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Jul 29, 1988 |
| Received | Apr 28, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881817
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.