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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK101307
Test Name Simple Diagnostics AG-6951 Multi 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 Date08/16/2011
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
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