510(k) K261686 ยท SET Immunoassay Blood Test For Amyloid Pathology Assessment
Elecsys Phospho-Tau (217P) Plasma
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 19, 2026 |
| Received | May 21, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261686
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.