510(k) K914806 ยท DIF Drug Mixture Control Materials
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Nov 19, 1991 |
| Received | Oct 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914806
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.