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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
Requester
renalytix ai, inc.
1460 broadway
new york,  NY  10036
Contact joe hutson
Regulation Number862.1223
Classification Product Code
QWZ  
Date Received08/26/2020
Decision Date 06/29/2023
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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