510(k) K910617 ยท DDF Prothrombin, Antigen, Antiserum, Control
NATIVE PROTHROMBIN ANTIGEN EIA
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, May 15, 1991 |
| Received | Feb 12, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910617
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.