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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK133389
Test Name EPS Bio Technology Corp EM40 Pro Blood Glucose System  
Manufacturer NameEPS BIO TECHNOLOGY CORP.
Consumer Information Phone Number(866)994-3345
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date04/17/2014
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K133389
Device Name EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
Applicant
EPS BIO TECHNOLOGY CORP.
NO.8 R&D RD III
HSINCHU SCIENCE PARK
HSINCHU CITY,,  TW 30077
Applicant Contact Cynthia Hung
Correspondent
EPS BIO TECHNOLOGY CORP.
NO.8 R&D RD III
HSINCHU SCIENCE PARK
HSINCHU CITY,,  TW 30077
Correspondent Contact Cynthia Hung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received11/05/2013
Decision Date 04/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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