510(k) K965076 ยท KFF Assay, Heparin
MDA HEPARIN ANTI-X ASSAY
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Mar 18, 1997 |
| Received | Dec 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965076
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.