510(k) K041478

BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR by Becton Dickinson — Product Code CGA

K041478 is an FDA 510(k) premarket notification submitted by Becton Dickinson for the device "BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR". The FDA issued a decision of Substantially Equivalent on October 28, 2004. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Becton Dickinson has at least 5 other 510(k) clearances on record.