CIW · Class II · 21 CFR 862.1070

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

Leading manufacturers include Boehringer Mannheim Corp., Pharmacia, Inc. and Calbiochem-Behring Corp..

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 Oct 28, 1993
DMA AMYLASE PROCEDURE
K931559
Data Medical Associates, Inc.
Chemistry · 212d
Cleared Oct 19, 1992
OLYMPUS AMYLASE REAGENT
K924339
Olympus Corp.
Chemistry · 52d
Cleared Jan 11, 1989
AMYLASE TEST (AMYL) ITEM NUMBER: 65653
K884382
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Mar 05, 1985
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
K850639
Bio-Analytics Laboratories, Inc.
Chemistry · 14d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
K812027
Eastman Kodak Company
Chemistry · 14d
Cleared May 13, 1981
PHADEBAS ISOAMYLASE TEST
K810584
Pharmacia, Inc.
Chemistry · 70d
Cleared Mar 31, 1981
PANTRAK E.K.
K810669
Calbiochem-Behring Corp.
Chemistry · 19d
Cleared Mar 02, 1979
UNITEST AMYLASE
K782032
Boehringer Mannheim Corp.
Chemistry · 86d

About Product Code CIW - Regulatory Context