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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 K091102
Device Name ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
Applicant
Arkray Factory USA, Inc.
5182 W. 76th St.
Edina,  MN  55439
Applicant Contact HAMID IDRISSI
Correspondent
Arkray Factory USA, Inc.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact HAMID IDRISSI
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received04/16/2009
Decision Date 10/23/2009
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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