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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name aquaporin-4 autoantibody
De Novo Number DEN150030
Device Name KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
Requester
kronus, inc.
170 s. seneca springs way, suite 105
star,  ID  83669
Contact brian deis
Regulation Number866.5665
Classification Product Code
PNI  
Date Received07/02/2015
Decision Date 04/25/2016
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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