510(k) K252163 ยท SET Immunoassay Blood Test For Amyloid Pathology Assessment
Elecsys Phospho-Tau (181P) Plasma
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 8, 2025 |
| Received | Jul 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252163
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.