FDA Product Code CDD: Radioassay, Vitamin B12
Leading manufacturers include Beckman Coulter, Inc. and Axis-Shield Diagnostics, Ltd..
FDA 510(k) Cleared Radioassay, Vitamin B12 Devices (Product Code CDD)
About Product Code CDD - Regulatory Context
510(k) Submission Activity
78 total 510(k) submissions under product code CDD since 1976, with 78 receiving FDA clearance (average review time: 98 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 CDD have taken an average of 271 days to reach a decision - up from 96 days historically. Manufacturers should account for longer review timelines in current project planning.
CDD devices are reviewed by the Chemistry panel. Browse all Chemistry devices →