510(k) K143534 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Elecsys CA-125 II assay
| Applicant | Roche Professional Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 6, 2015 |
| Received | Dec 12, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143534
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.