510(k) K253528 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Atellica IM CA 19-9 II
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Aug 10, 2026 |
| Received | Nov 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253528
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.