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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K183306
Device Name GLUCOCARD® W onyx Blood Glucose Monitoring System
Applicant
Arkray Factory, Inc.
Yousuien-Nai 59 Gansuin-Cho
Kamigyo-Ku,  JP 602-0008
Applicant Contact Yoshiharu Uehata
Correspondent
Arkra Y America, Inc.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact Dhwani Thakkar
Regulation Number862.1345
Classification Product Code
NBW  
Date Received11/28/2018
Decision Date 04/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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