FDA Product Code DGC: Ige, Antigen, Antiserum, Control
Leading manufacturers include Kenota, Inc., Biokit, S.A. and Beckman Coulter, Inc..
FDA 510(k) Cleared Ige, Antigen, Antiserum, Control Devices (Product Code DGC)
About Product Code DGC - Regulatory Context
510(k) Submission Activity
114 total 510(k) submissions under product code DGC since 1977, with 114 receiving FDA clearance (average review time: 65 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under DGC have taken an average of 403 days to reach a decision - up from 62 days historically. Manufacturers should account for longer review timelines in current project planning.
DGC devices are reviewed by the Immunology panel. Browse all Immunology devices →