510(k) K253240 ยท SET Immunoassay Blood Test For Amyloid Pathology Assessment
PrecivityAD2 Test
| Applicant | C2N Diagnostics, LLC, St. Louis MO, US |
| Decision | Substantially Equivalent, Aug 19, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253240
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.