FDA 510(k) Applications for Medical Device Product Code "KWW"
(Radioimmunoassay, Cholyglycine, Bile Acids)

FDA 510(k) Number Applicant Device Name Decision Date
K062503 CATACHEM, INC. CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT 01/19/2007
K051714 DIAZYME LABORATORIES TOTAL BILE ACIDS ASSAY, MODEL DZ042A 12/07/2005
K970120 TECO DIAGNOSTICS BILE ACIDS REAGENT SET 03/24/1997


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