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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K142336
Device Name GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
Applicant
Arkray Factory, Inc.
1480 Koji, Konan-Cho
Koka-Shi,  JP 520-3306
Applicant Contact Kazuya Yorimitsu
Correspondent
Arkray Factory USA, Inc.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact Lonna M DenDooven
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received08/21/2014
Decision Date 09/17/2014
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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