FDA 510(k) Application Details - K201902

Device Classification Name	Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer   More FDA Info for this Device
510(K) Number	K201902
Device Name	Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Applicant	Agendia Inc. 22 Morgan Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Marcelo Trevino Other 510(k) Applications for this Contact
Regulation Number	866.6040   More FDA Info for this Regulation Number
Classification Product Code	NYI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/2020
Decision Date	11/05/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review