K-number	DEN200072
Device name	Lumipulse G ß-Amyloid Ratio (1-42/1-40)
Applicant	Fujirebio Diagnostics,Inc.
Product code	QSE
Device class	Class II
Decision date	May 4, 2022
Decision	Not Substantially Equivalent
Regulation	866.5840

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Lumipulse G ß-Amyloid Ratio (1-42/1-40)

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