510(k) K111874

FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS by Abbott Laboratories — Product Code LFR

K111874 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS". The FDA issued a decision of Substantially Equivalent on February 16, 2012. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Abbott Laboratories has at least 10 other 510(k) clearances on record.