FDA Product Code DCK: C-reactive Protein, Antigen, Antiserum, And Control
Leading manufacturers include Kamiya Biomedical Company, LLC.
FDA 510(k) Cleared C-reactive Protein, Antigen, Antiserum, And Control Devices (Product Code DCK)
About Product Code DCK - Regulatory Context
510(k) Submission Activity
126 total 510(k) submissions under product code DCK since 1976, with 126 receiving FDA clearance (average review time: 94 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 DCK have taken an average of 268 days to reach a decision - up from 93 days historically. Manufacturers should account for longer review timelines in current project planning.
DCK devices are reviewed by the Immunology panel. Browse all Immunology devices →