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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK142035
Test Name Wal-Mart Stores, Inc. ReliOn MICRO Blood Glucose Monitoring System  
Manufacturer NameARKRAY FACTORY INC.
Consumer Information Phone Number1(855)566-8558
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date10/01/2014
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K142035
Device Name GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM
Applicant
ARKRAY FACTORY INC.
5182 WEST 76TH ST
EDINA,  MN  55439
Applicant Contact LONNA M DENDOOVEN
Correspondent
ARKRAY FACTORY INC.
5182 WEST 76TH ST
EDINA,  MN  55439
Correspondent Contact LONNA M DENDOOVEN
Regulation Number862.1345
Classification Product Code
NBW  
Date Received07/28/2014
Decision Date 09/05/2014
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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