510(k) K092602

FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System by Abbott Diabetes Care, Inc. — Product Code NBW

K092602 is an FDA 510(k) premarket notification submitted by Abbott Diabetes Care, Inc. for the device "FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on May 14, 2010. 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.