510(k) K915746 ยท GJS Test, Time, Prothrombin
SIMPLASTIN L
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Feb 12, 1992 |
| Received | Dec 23, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915746
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.