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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 K124021
Device Name ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
Applicant
ARKRAY FACTORY INC.
5198 WEST 76TH ST
EDINA,  MN  55439
Applicant Contact LONNA M DENDOOVEN
Correspondent
ARKRAY FACTORY INC.
5198 WEST 76TH ST
EDINA,  MN  55439
Correspondent Contact LONNA M DENDOOVEN
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received12/27/2012
Decision Date 06/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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