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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK090332
Test Name Arkray USA Inc. Assure Pro Blood Glucose Monitoring System  
Manufacturer NameArkray Factory USA, Inc.
Consumer Information Phone Number(800)818-8877
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date09/01/2009
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K090332
Device Name ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
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
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received02/10/2009
Decision Date 08/14/2009
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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