FDA 510(k) Application Details - K181661

Device Classification Name	More FDA Info for this Device
510(K) Number	K181661
Device Name	QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
Applicant	Bio-Rad Laboratories, Inc. 5731 W. Las Positas Blvd Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Steve Lin 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	06/25/2018
Decision Date	02/13/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MG -
Review Advisory Committee	MG -
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review