FDA 510(k) Application Details - K161951

Device Classification Name	More FDA Info for this Device
510(K) Number	K161951
Device Name	KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
Applicant	KRONUS, INC. 170 S. SENECA SPRINGS WAY, SUITE 105 STAR, ID 83669 US Other 510(k) Applications for this Company
Contact	Brian Deis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2016
Decision Date	07/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review