Elecsys Phospho-Tau (181P) Plasma— 510(k) K252163

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K252163 for Elecsys Phospho-Tau (181P) Plasma, Substantially Equivalent on 2025-10-08. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code SET
Advisory panel: Immunology
Date received: 2025-07-10
Decision date: 2025-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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