510(k) K911634

MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST by Immunotech Corp. — Product Code CEC

K911634 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST". The FDA issued a decision of Substantially Equivalent on June 24, 1991. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Immunotech Corp. has at least 10 other 510(k) clearances on record.