510(k) K221355 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
| Applicant | Ortho Clinical Diagnostics, Bridgend, GB |
| Decision | Substantially Equivalent, Dec 12, 2022 |
| Received | May 10, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221355
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.