FDA Product Code DFC: Lipoprotein, Low-density, Antigen, Antiserum, Control
Leading manufacturers include Roche Diagnostics Operations.
FDA 510(k) Cleared Lipoprotein, Low-density, Antigen, Antiserum, Control Devices (Product Code DFC)
About Product Code DFC - Regulatory Context
510(k) Submission Activity
42 total 510(k) submissions under product code DFC since 1977, with 42 receiving FDA clearance (average review time: 103 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 DFC have taken an average of 268 days to reach a decision - up from 99 days historically. Manufacturers should account for longer review timelines in current project planning.
DFC devices are reviewed by the Chemistry panel. Browse all Chemistry devices →