510(k) K954291 ยท DIF Drug Mixture Control Materials
OPUS TDM CONTROLS
| Applicant | Behring Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Nov 20, 1995 |
| Received | Sep 14, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954291
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.