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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 K063771
Device Name GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Arkray Factory USA, Inc.
5182 W. 76th St.
Edina,  MN  55439
Applicant Contact TOM SPEIKERS
Correspondent
Arkray Factory USA, Inc.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact TOM SPEIKERS
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received12/21/2006
Decision Date 08/09/2007
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
Predetermined Change
Control Plan Authorized		 No
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