510(k) K874875

CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) by Boots-Celltech Diagnostics, Inc. — Product Code CEC

K874875 is an FDA 510(k) premarket notification submitted by Boots-Celltech Diagnostics, Inc. for the device "CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)". The FDA issued a decision of Substantially Equivalent on March 24, 1988. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Boots-Celltech Diagnostics, Inc. has at least 10 other 510(k) clearances on record.