510(k) K803296

ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT by Immunotech Corp. — Product Code KWW

K803296 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT". The FDA issued a decision of Substantially Equivalent on January 16, 1981. The device falls under product code KWW (Radioimmunoassay, Cholyglycine, Bile Acids), a Class II device regulated under 21 CFR 862.1177. Immunotech Corp. has at least 10 other 510(k) clearances on record.