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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 brain trauma assessment test
De Novo Number DEN170045
Device Name Banyan BTI
Banyan Biomarkers, Inc.
16470 west bernardo drive
suite 100
san diego,  CA  92127
Contact steven p. richieri
Regulation Number866.5830
Classification Product Code
Date Received08/28/2017
Decision Date 02/14/2018
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct