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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK113192
Test Name Infopia USA, LLC. Healthpro Blood Glucose Monitoring System  
Manufacturer NameINFOPIA CO., LTD
Consumer Information Phone Number1(888)446-3246
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date07/23/2012
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K113192
Device Name HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
Applicant
INFOPIA CO., LTD
951 STARBUCK ST. UNIT J
FULLERTON,  CA  92833
Applicant Contact Priscilla Chung
Correspondent
INFOPIA CO., LTD
951 STARBUCK ST. UNIT J
FULLERTON,  CA  92833
Correspondent Contact Priscilla Chung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received10/31/2011
Decision Date 07/13/2012
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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