FDA Product Code DCN: System, Test, C-reactive Protein
Leading manufacturers include Siemens Healthcare Diagnostics, Inc..
70
Total
70
Cleared
94d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared System, Test, C-reactive Protein Devices (Product Code DCN)
70 devices
About Product Code DCN - Regulatory Context
510(k) Submission Activity
70 total 510(k) submissions under product code DCN since 1977, with 70 receiving FDA clearance (average review time: 94 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
DCN devices are reviewed by the Immunology panel. Browse all Immunology devices →