FDA 510(k) Application Details - K200009

Device Classification Name	More FDA Info for this Device
510(K) Number	K200009
Device Name	Adaptive Biotechnologies clonoSEQ Assay
Applicant	Adaptive Biotechnologies Corporation 1551 Eastlake Ave E., Ste 200 Seattle, WA 98102 US Other 510(k) Applications for this Company
Contact	Megan Duncan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2020
Decision Date	08/05/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	MG -
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review