IGE · Class I · 21 CFR 864.4010

FDA Product Code IGE: Solution, Formalin Ammonium Bromide

Leading manufacturers include Anatech, Ltd. and Busse Hospital Disposables, Inc..

2
Total
2
Cleared
74d
Avg days
1984
Since

FDA 510(k) Cleared Solution, Formalin Ammonium Bromide Devices (Product Code IGE)

2 devices
1–2 of 2
Cleared May 30, 1995
SALINE SOLUTINE, STERILE
K950560
Busse Hospital Disposables, Inc.
Pathology · 111d
Cleared Aug 28, 1984
CB FORMALIN
K842862
Anatech, Ltd.
Pathology · 36d

About Product Code IGE - Regulatory Context