510(k) K983434

ABBOTT ARCHITECT TOTAL T3 by Abbott Laboratories — Product Code CDP

K983434 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT ARCHITECT TOTAL T3". The FDA issued a decision of Substantially Equivalent on November 20, 1998. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Abbott Laboratories has at least 10 other 510(k) clearances on record.