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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K133647
Device Name EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
Applicant
Eps Bio Technology Corp.
# 8 R&D Rd.Iii, Hsinchu Science Park
Hsinchu,  TW 30077
Applicant Contact Cynthia Hung
Correspondent
Eps Bio Technology Corp.
# 8 R&D Rd.Iii, Hsinchu Science Park
Hsinchu,  TW 30077
Correspondent Contact Cynthia Hung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received11/27/2013
Decision Date 02/27/2014
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
Predetermined Change
Control Plan Authorized		 No
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