K-number	DEN200052
Device name	KidneyIntelX.dkd
Applicant	Renalytix Ai, Inc.
Product code	QWZ
Device class	Class II
Decision date	Jun 29, 2023
Decision	Not Substantially Equivalent
Regulation	862.1223

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Source

View the full FDA submission: accessdata.fda.gov

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KidneyIntelX.dkd

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