510(k) K120568

FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM by Abbott Diabetes Care, Inc. — Product Code NBW

K120568 is an FDA 510(k) premarket notification submitted by Abbott Diabetes Care, Inc. for the device "FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 29, 2012. 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, Inc. has at least 10 other 510(k) clearances on record.