510(k) K103544

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

K103544 is an FDA 510(k) premarket notification submitted by Agamatrix, Inc. for the device "IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D". The FDA issued a decision of Substantially Equivalent on December 7, 2011. 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.