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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 K082328
Device Name GLUCODR PLUS SYSTEM, MODEL AGM-3000
Applicant
All Medicus Co., Ltd.
823 Gwanyang 2-Dong
Dongan-Gu
Anyang, Gyeonggi-Do,  KR 431-062
Applicant Contact MARGARET KIM
Correspondent
All Medicus Co., Ltd.
823 Gwanyang 2-Dong
Dongan-Gu
Anyang, Gyeonggi-Do,  KR 431-062
Correspondent Contact MARGARET KIM
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received08/14/2008
Decision Date 02/27/2009
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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