510(k) K894463 ยท LAS Drug Specific Control Materials
ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Aug 21, 1989 |
| Received | Jul 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894463
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.