510(k) K812985 ยท DDF Prothrombin, Antigen, Antiserum, Control
AGGLUTEX MORPHINE TEST KIT
| Applicant | Hoffmann-La Roche, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 31, 1981 |
| Received | Oct 26, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812985
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.