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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Urine Particle
510(k) Number K232416
Device Name AUTION EYE AI-4510 Urine Particle Analysis System
Applicant
Arkray, Inc.
Yousuien-Nai, 59 Gansuin-Cho
Kamigyo-Ku
Kyoto,  JP 602-0008
Applicant Contact Shinya Nakajima
Correspondent
Arkray, Inc.
5198 W. 76th St.
Edina,  MN  55439
Correspondent Contact Daya Ranamukhaarachi
Regulation Number864.5200
Classification Product Code
LKM  
Subsequent Product Code
KQO  
Date Received08/11/2023
Decision Date 05/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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