KidneyIntelX.dkd

KidneyIntelX.dkd is an FDA 510(k)-cleared medical device (DEN200052) manufactured by Renalytix Ai, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2023. Regulation: 8.