510(k) K130094

FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM by Abbott Diabetes Care — Product Code NBW

K130094 is an FDA 510(k) premarket notification submitted by Abbott Diabetes Care for the device "FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 27, 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. Abbott Diabetes Care has at least 10 other 510(k) clearances on record.