DCE · Class I · 21 CFR 866.5520

FDA Product Code DCE: Fab, Antigen, Antiserum, Control

Leading manufacturers include Kallestad Laboratories, Inc..

2
Total
2
Cleared
49d
Avg days
1977
Since

FDA 510(k) Cleared Fab, Antigen, Antiserum, Control Devices (Product Code DCE)

2 devices
1–2 of 2
Cleared Feb 16, 1979
ANTISERA, RHODAMINE CONJUGATED FRAGMENT
K781951
Kallestad Laboratories, Inc.
Immunology · 87d
Cleared Nov 22, 1977
FLUORESCEIN CONJUGATED
K772128
Kallestad Laboratories, Inc.
Immunology · 11d

About Product Code DCE - Regulatory Context