510(k) K902194

MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT by Immunotech Corp. — Product Code DJG

K902194 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on July 17, 1990. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Immunotech Corp. has at least 10 other 510(k) clearances on record.