510(k) clearance

Elecsys Phospho-Tau (217P) Plasma

FDA 510(k) source

510(k) number

K261686

Applicant

Roche Diagnostics

Decision date

Aug 19, 2026

Date received

May 21, 2026

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

Indianapolis, IN, US