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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K082121
Device Name EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
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
CGA  
Subsequent Product Codes
JJY   NBW  
Date Received07/28/2008
Decision Date 09/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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