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U.S. Department of Health and Human Services

OTC - Over The Counter

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Document NumberK102345
Test Name EPS Bio Technology Corp EasyMax T1 Pro Self-Monitoring Blood Glucose System  
Manufacturer NameEPS BIO TECHNOLOGY CORP.
Consumer Information Phone Number1(866)994-3345
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date06/23/2011
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K102345
Device Name EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
Applicant
EPS BIO TECHNOLOGY CORP.
NO.8 R&D RD III
HSINCHU SCIENCE PARK
HSINCHU CITY,  TW 30077
Applicant Contact Y.C. LEI
Correspondent
EPS BIO TECHNOLOGY CORP.
NO.8 R&D RD III
HSINCHU SCIENCE PARK
HSINCHU CITY,  TW 30077
Correspondent Contact Y.C. LEI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received08/19/2010
Decision Date 06/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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