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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name prognostic test for assessment of chronic kidney disease progression
De Novo Number DEN200052
Device Name KidneyIntelX.dkd
Renalytix AI, Inc.
1460 broadway
new york,  NY  10036
Contact joe hutson
Regulation Number862.1223
Classification Product Code
Date Received08/26/2020
Decision Date 06/29/2023
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
Type Direct