510(k) K130535

IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION by Agamatrix, Inc. — Product Code NBW

K130535 is an FDA 510(k) premarket notification submitted by Agamatrix, Inc. for the device "IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION". The FDA issued a decision of Substantially Equivalent on April 17, 2013. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Agamatrix, Inc. has at least 10 other 510(k) clearances on record.