510(k) K925617 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
MDA PROTEIN ASSAY
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Jan 27, 1994 |
| Received | Nov 6, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925617
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.