KWW · Class II · 21 CFR 862.1177

FDA Product Code KWW: Radioimmunoassay, Cholyglycine, Bile Acids

Leading manufacturers include Diazyme Laboratories, Catachem, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

6
Total
6
Cleared
79d
Avg days
1978
Since

FDA 510(k) Cleared Radioimmunoassay, Cholyglycine, Bile Acids Devices (Product Code KWW)

6 devices
1–6 of 6
Cleared Jan 19, 2007
CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
K062503
Catachem, Inc.
Chemistry · 147d
Cleared Dec 07, 2005
TOTAL BILE ACIDS ASSAY, MODEL DZ042A
K051714
Diazyme Laboratories
Chemistry · 163d
Cleared Mar 24, 1997
BILE ACIDS REAGENT SET
K970120
Teco Diagnostics
Chemistry · 69d
Cleared Aug 26, 1987
BILE ACIDS REAGENT
K872296
Sigma Diagnostics, Inc.
Chemistry · 71d
Cleared Jan 16, 1981
ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT
K803296
Immunotech Corp.
Chemistry · 17d
Cleared Aug 11, 1978
CONJUGATED BILE ACIDS RIA KIT
K781337
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 8d

About Product Code KWW - Regulatory Context