510(k) K903993

MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT by Immunotech Corp. — Product Code DKZ

K903993 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT". The FDA issued a decision of Substantially Equivalent on December 20, 1990. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Immunotech Corp. has at least 10 other 510(k) clearances on record.