FDA Product Code DDG: Transferrin, Antigen, Antiserum, Control
Leading manufacturers include Beckman Coulter, Inc..
FDA 510(k) Cleared Transferrin, Antigen, Antiserum, Control Devices (Product Code DDG)
About Product Code DDG - Regulatory Context
510(k) Submission Activity
48 total 510(k) submissions under product code DDG since 1977, with 48 receiving FDA clearance (average review time: 97 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for DDG submissions have been consistent, averaging 84 days recently vs 98 days historically.
DDG devices are reviewed by the Immunology panel. Browse all Immunology devices →