510(k) K904635

MICROZYME THC ENZYME IMMUNOASSAY TEST KIT by Immunotech Corp. — Product Code LDJ

K904635 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "MICROZYME THC ENZYME IMMUNOASSAY TEST KIT". The FDA issued a decision of Substantially Equivalent on November 1, 1990. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Immunotech Corp. has at least 10 other 510(k) clearances on record.