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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 K102678
Device Name ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
Applicant
Andon Medical Co., Ltd.
# 04-23-3 Airport Industrial
Park, Tianjin
Tianjin,  CN 300381
Applicant Contact YI LIU
Correspondent
Andon Medical Co., Ltd.
# 04-23-3 Airport Industrial
Park, Tianjin
Tianjin,  CN 300381
Correspondent Contact YI LIU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received09/16/2010
Decision Date 08/26/2011
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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