510(k) K902922

MICROZYME T4 ENZYME IMMUNOASSAY KIT by Immunotech Corp. — Product Code CDX

K902922 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "MICROZYME T4 ENZYME IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on July 27, 1990. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Immunotech Corp. has at least 10 other 510(k) clearances on record.