FDA Product Code CGN: Acid, Folic, Radioimmunoassay
Leading manufacturers include Beckman Coulter, Inc. and Roche Diagnostics.
FDA 510(k) Cleared Acid, Folic, Radioimmunoassay Devices (Product Code CGN)
About Product Code CGN - Regulatory Context
510(k) Submission Activity
64 total 510(k) submissions under product code CGN since 1976, with 64 receiving FDA clearance (average review time: 85 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 CGN have taken an average of 266 days to reach a decision - up from 82 days historically. Manufacturers should account for longer review timelines in current project planning.
CGN devices are reviewed by the Chemistry panel. Browse all Chemistry devices →