K242706

Substantially Equivalent

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio

Applicant: Fujirebio Diagnostics,Inc.
Product code: SET
Advisory panel: Immunology
Date received: 2024-09-09
Decision date: 2025-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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