510(k) K905777

MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT by Immunotech Corp. — Product Code CEE

K905777 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on January 30, 1991. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Immunotech Corp. has at least 10 other 510(k) clearances on record.