510(k) K781225

GLOBULIN TEST, HUMAN THYROXINE BINDING by Hyland Therapeutic Div., Travenol Laboratories — Product Code CEE

K781225 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "GLOBULIN TEST, HUMAN THYROXINE BINDING". The FDA issued a decision of Substantially Equivalent on August 31, 1978. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.