510(k) K123379

ABBOTT ARCHITECT FREE T4 by Abbott Laboratories — Product Code CEC

K123379 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT ARCHITECT FREE T4". The FDA issued a decision of Substantially Equivalent on November 27, 2012. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Abbott Laboratories has at least 10 other 510(k) clearances on record.