FDA 510(k) Application Details - DEN170045

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170045
Device Name	Banyan BTI
Applicant	Banyan Biomarkers, Inc. 16470 West Bernardo Drive Suite 100 San Diego, CA 92127 US Other 510(k) Applications for this Company
Contact	Steven P. Richieri Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2017
Decision Date	02/14/2018
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review