FDA 510(k) Application Details - DEN200052

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200052
Device Name	KidneyIntelX.dkd
Applicant	Renalytix AI, Inc. 1460 Broadway New York, NY 10036 US Other 510(k) Applications for this Company
Contact	Joe Hutson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2020
Decision Date	06/29/2023
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review