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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 K061992
Device Name EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
Applicant
Eps Bio Technology Corp.
2 F,#49-2, Ln. 2, Sec. 2,
Guang Fu Rd.
Hsinchu City,  TW 300
Applicant Contact Y C LEI
Correspondent
Eps Bio Technology Corp.
2 F,#49-2, Ln. 2, Sec. 2,
Guang Fu Rd.
Hsinchu City,  TW 300
Correspondent Contact Y C LEI
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received07/13/2006
Decision Date 09/19/2006
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
Predetermined Change
Control Plan Authorized		 No
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