FDA 510(k) Application Details - K221640

Device Classification Name	Cardiac Allograft Gene Expression Profiling Test System   More FDA Info for this Device
510(K) Number	K221640
Device Name	Cardiac Allograft Gene Expression Profiling Test System
Applicant	CareDx, Inc. 3260 Bayshore Boulevard Brisbane, CA 94005 US Other 510(k) Applications for this Company
Contact	Camilla Lu Other 510(k) Applications for this Contact
Regulation Number	862.1163   More FDA Info for this Regulation Number
Classification Product Code	OJQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2022
Decision Date	09/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review