510(k) K231525 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
| Applicant | Ortho Clinical Diagnostics, Bridgend, GB |
| Decision | Substantially Equivalent, Aug 9, 2023 |
| Received | May 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231525
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.