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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aquaporin-4 Autoantibody
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
Applicant Contact Brian Deis
Correspondent
Kronus, Inc.
170 S. Seneca Springs Way
Suite 105
Star,  ID  83669
Correspondent Contact Brian Deis
Regulation Number866.5665
Classification Product Code
PNI  
Date Received07/15/2016
Decision Date 07/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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