K-number	K221842
Device name	Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
Applicant	Roche Diagnostics
Product code	QSE
Device class	Class II
Decision date	Dec 7, 2022
Decision	Substantially Equivalent
Regulation	866.5840

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View the full FDA submission: accessdata.fda.gov

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Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

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