K253240
- 510(k) number
- K253240
- Device name
- PrecivityAD2 Test
- Applicant
- C2N Diagnostics, LLC MO · US
- Product code
- SET — Immunoassay Blood Test For Amyloid Pathology Assessm
- Decision date
- 2026-08-19
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K253240.pdf
Official FDA record: K253240
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.