510(k) K062503

CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT by Catachem, Inc. — Product Code KWW

K062503 is an FDA 510(k) premarket notification submitted by Catachem, Inc. for the device "CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT". The FDA issued a decision of Substantially Equivalent on January 19, 2007. The device falls under product code KWW (Radioimmunoassay, Cholyglycine, Bile Acids), a Class II device regulated under 21 CFR 862.1177. Catachem, Inc. has at least 10 other 510(k) clearances on record.