FDA 510(k) Application Details - DEN220090

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220090
Device Name	EasySepÖ Human Bone Marrow CD138 Positive Selection Kit (100-0748)
Applicant	STEMCELL Technologies Canada Inc. 1618 Station Street Vancouver V6A 1B6 CA Other 510(k) Applications for this Company
Contact	Jason Peng Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2022
Decision Date	11/06/2023
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review