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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 K050985
Device Name GLUCODR SUPERSENSOR SYSTEM
Applicant
All Medicus Co., Ltd.
7106 Dong-Il Techo Town 7th
823 Kwanyang Dong Dongan-Gu
Anyang, Gyeonggi-Do,  KR 431-062
Applicant Contact JE YOUNG CHANG
Correspondent
All Medicus Co., Ltd.
7106 Dong-Il Techo Town 7th
823 Kwanyang Dong Dongan-Gu
Anyang, Gyeonggi-Do,  KR 431-062
Correspondent Contact JE YOUNG CHANG
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received04/19/2005
Decision Date 10/07/2005
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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