K-number	DEN150030
Device name	KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
Applicant	Kronus, Inc.
Product code	PNI
Device class	Class II
Decision date	Apr 25, 2016
Decision	Not Substantially Equivalent
Regulation	866.5665

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View the full FDA submission: accessdata.fda.gov

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KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

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