CIW · Class II · 21 CFR 862.1070

FDA Product Code CIW: Starch-dye Bound Polymer, Amylase

Leading manufacturers include Boehringer Mannheim Corp., Eastman Kodak Company and Em Diagnostic Systems, Inc..

8
Total
8
Cleared
69d
Avg days
1979
Since

FDA 510(k) Cleared Starch-dye Bound Polymer, Amylase Devices (Product Code CIW)

8 devices
1–8 of 8
Cleared Jan 11, 1989
AMYLASE TEST (AMYL) ITEM NUMBER: 65653
K884382
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
K812027
Eastman Kodak Company
Chemistry · 14d
Cleared Mar 02, 1979
UNITEST AMYLASE
K782032
Boehringer Mannheim Corp.
Chemistry · 86d

About Product Code CIW - Regulatory Context