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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK081796
Test Name EPS Bio Technology Corp. EasyPlus mini R2N Self-Monitoring Blood Glucose Test System  
Manufacturer NameEps Bio Technology Corp.
Consumer Information Phone Number1(866)203-2761
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date01/27/2009
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K081796
Device Name EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
Applicant
Eps Bio Technology Corp.
2 F,# 49-2, Ln. 2, Sec. 2,
Guang Fu Rd.
Hsinchu City,  TW 30071
Applicant Contact Y.C. LEI
Correspondent
Eps Bio Technology Corp.
2 F,# 49-2, Ln. 2, Sec. 2,
Guang Fu Rd.
Hsinchu City,  TW 30071
Correspondent Contact Y.C. LEI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received06/25/2008
Decision Date 01/23/2009
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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