510(k) K854009 ยท DJP Radioimmunoassay, Amphetamine
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
| Applicant | Roche Diagnostic Systems, Inc., Belleville NJ, US |
| Decision | Substantially Equivalent, Oct 15, 1985 |
| Received | Sep 30, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854009
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.