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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK101037
Test Name EPS Bio Technology Corp EG V1 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 Date06/02/2011
Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K101037
Device Name EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
Applicant
Eps Bio Technology Corp.
# 8 R&D Rd.Iii, Hsinchu Science Park
Hsinchu,  TW 30077
Applicant Contact YC LEI
Correspondent
Eps Bio Technology Corp.
# 8 R&D Rd.Iii, Hsinchu Science Park
Hsinchu,  TW 30077
Correspondent Contact YC LEI
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received04/14/2010
Decision Date 05/23/2011
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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