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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 K040678
Device Name EUSURE BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Eumed Biotechnology Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Applicant Contact Ke-Min Jen
Correspondent
Eumed Biotechnology Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Correspondent Contact Ke-Min Jen
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received03/15/2004
Decision Date 07/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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