510(k) K913722 ยท KLN Radioimmunoassay, Cocaine Metabolite
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Sep 10, 1991 |
| Received | Aug 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913722
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.