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U.S. Department of Health and Human Services

OTC - Over The Counter

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Document NumberK103544
Test Name sanofi-aventis U.S. LLC iBGStar Blood Glucose Monitoring System  
Manufacturer NameAGAMATRIX INC
Consumer Information Phone Number(800)633-1610
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date12/07/2011
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K103544
Device Name IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
Applicant
AGAMATRIX INC
7C RAYMOND AVE
SALEM,  NH  03079
Applicant Contact WILLIAM H MCGRAIL
Correspondent
AGAMATRIX INC
7C RAYMOND AVE
SALEM,  NH  03079
Correspondent Contact WILLIAM H MCGRAIL
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX   JQP  
Date Received12/02/2010
Decision Date 12/07/2011
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
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