510(k) K983440

ABBOTT ARCHITECT TOTAL T4 by Abbott Laboratories — Product Code KLI

K983440 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT ARCHITECT TOTAL T4". The FDA issued a decision of Substantially Equivalent on November 25, 1998. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Abbott Laboratories has at least 10 other 510(k) clearances on record.