DGE · Class II · 21 CFR 866.5510

FDA Product Code DGE: Igd, Rhodamine, Antigen, Antiserum, Control

Leading manufacturers include American Dade and Pb Diagnostic Systems, Inc..

2
Total
2
Cleared
73d
Avg days
1987
Since

FDA 510(k) Cleared Igd, Rhodamine, Antigen, Antiserum, Control Devices (Product Code DGE)

2 devices
1–2 of 2
Cleared Mar 18, 1992
OPUS FERRITIN TEST SYSTEM
K915838
Pb Diagnostic Systems, Inc.
Immunology · 85d
Cleared Jul 21, 1987
STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY
K871972
American Dade
Immunology · 61d

About Product Code DGE - Regulatory Context