FDA 510(k) Application Details - DEN160003

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160003
Device Name	Quantidex qPCR BCR-ABL IS Kit
Applicant	ASURAGEN, INC. 2150 WOODWARD, SUITE 100 AUSTIN, TX 78744 US Other 510(k) Applications for this Company
Contact	FAYYAZ MEMON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2016
Decision Date	07/22/2016
Decision	DENG -
Classification Advisory Committee	MG -
Review Advisory Committee	MG -
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review