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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K121207
Device Name EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO 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
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received04/20/2012
Decision Date 05/18/2012
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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