510(k) K042731 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
ARCHITECT CA 125 II ASSAY
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Nov 19, 2004 |
| Received | Oct 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042731
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.