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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK110017
Test Name Simple Diagnostics AG-608N Single Blood Glucose Monitoring System  
Manufacturer NameAndon Medical Co., Ltd.
Consumer Information Phone Number(877)342-2385
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date01/23/2012
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K110017
Device Name AG-608N BLOOD GLUCOSE MONITORING SYSTEM
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 Codes
CGA   JJX  
Date Received01/03/2011
Decision Date 01/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01268345
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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