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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,NO. 49-2, LANE 2, SEC. 2,
GUANG FU ROAD
HSINCHU CITY,  TW 30071
Applicant Contact Y.C. LEI
Correspondent
EPS BIO TECHNOLOGY CORP.
2 F,NO. 49-2, LANE 2, SEC. 2,
GUANG FU ROAD
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
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