ICF · Class I · 21 CFR 864.1850

FDA Product Code ICF: Crystal Violet For Histology

Leading manufacturers include Volu Sol Medical Industries, Intl. Remote Imaging Systems and American Dade.

5
Total
5
Cleared
36d
Avg days
1979
Since

FDA 510(k) Cleared Crystal Violet For Histology Devices (Product Code ICF)

5 devices
1–5 of 5
Cleared Dec 22, 1986
TISSUE GRAM STAIN
K864531
Sigma Diagnostics, Inc.
Pathology · 35d
Cleared Oct 01, 1984
VON WILLEBRAND FACTOR ANTIGEN SCREEN
K842537
American Dade
Hematology · 95d
Cleared Aug 03, 1984
GENTIAN VIOLET
K842730
E K Ind., Inc.
Pathology · 21d
Cleared Jun 03, 1982
IRIS URINE STAIN
K821503
Intl. Remote Imaging Systems
Pathology · 15d
Cleared Dec 18, 1979
VOLU-SOL URINARY SEDIMENT STAIN
K792495
Volu Sol Medical Industries
Pathology · 14d

About Product Code ICF - Regulatory Context