510(k) K051714

TOTAL BILE ACIDS ASSAY, MODEL DZ042A by Diazyme Laboratories — Product Code KWW

K051714 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "TOTAL BILE ACIDS ASSAY, MODEL DZ042A". The FDA issued a decision of Substantially Equivalent on December 7, 2005. The device falls under product code KWW (Radioimmunoassay, Cholyglycine, Bile Acids), a Class II device regulated under 21 CFR 862.1177. Diazyme Laboratories has at least 10 other 510(k) clearances on record.