510(k) clearance

PrecivityAD2 Test

FDA 510(k) source

510(k) number

K253240

Applicant

C2N Diagnostics, LLC

Decision date

Aug 19, 2026

Date received

Sep 29, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

SET

Device type

Immunoassay Blood Test For Amyloid Pathology Assessment

Device class

Class II

Regulation

21 CFR 866.5840

Advisory committee

Immunology

Statement or summary

Summary

Third party

N

Location

St. Louis, MO, US