K-number	K231348
Device name	Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
Applicant	Roche Diagnostics
Product code	QSE
Device class	Class II
Decision date	Jun 5, 2023
Decision	Substantially Equivalent
Regulation	866.5840

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View the full FDA submission: accessdata.fda.gov

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Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF

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