510(k) K092638

FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 by Abbott Diabetes Care, Inc. — Product Code NBW

K092638 is an FDA 510(k) premarket notification submitted by Abbott Diabetes Care, Inc. for the device "FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23". The FDA issued a decision of Substantially Equivalent on June 15, 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.