510(k) K911745 ยท JCA Device, Bleeding Time
SIMPLATE PEDIATRIC
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Aug 9, 1991 |
| Received | Apr 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911745
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.