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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name alzheimer’s disease pathology assessment test
De Novo Number DEN200072
Device Name Lumipulse G ß-Amyloid Ratio (1-42/1-40)
Fujirebio Diagnostics, Inc.
201 great valley parkway
malvern,  PA  19355
Contact stacey dolan
Regulation Number866.5840
Classification Product Code
Date Received11/20/2020
Decision Date 05/04/2022
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct