510(k) K140371

FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) by Abbott Diabetes Care, Inc. — Product Code NBW

K140371 is an FDA 510(k) premarket notification submitted by Abbott Diabetes Care, Inc. for the device "FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)". The FDA issued a decision of Substantially Equivalent on September 30, 2014. 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.