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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 K130535
Device Name IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION
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 Code
JQP  
Date Received03/01/2013
Decision Date 04/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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