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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 K101307
Device Name BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
Applicant
Andon Medical Co., Ltd.
04-23-3 Airport Industrial Pk
Tianjin,  CN 300381
Applicant Contact YI LIU
Correspondent
Andon Medical Co., Ltd.
04-23-3 Airport Industrial Pk
Tianjin,  CN 300381
Correspondent Contact YI LIU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received05/10/2010
Decision Date 08/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00976924
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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