FDA Product Code DGC: Ige, Antigen, Antiserum, Control
Leading manufacturers include Biokit, S.A. and Beckman Coulter, Inc..
2
Total
2
Cleared
241d
Avg days
2022
Since
List of Ige, Antigen, Antiserum, Control devices cleared through 510(k)
2 devices
Cleared
Feb 21, 2023
Quantia IgE
Biokit, S.A.
Immunology
421d
Cleared
Mar 23, 2022
Total Immunoglobulin E (IgE)
Beckman Coulter, Inc.
Immunology
61d
How to use this database
This page lists all FDA 510(k) submissions for Ige, Antigen, Antiserum, Control devices (product code DGC). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Immunology FDA review panel. Browse all Immunology devices →