FDA Product Code CFN: Method, Nephelometric, Immunoglobulins (g, A, M)
Leading manufacturers include Siemens Healthcare Diagnostics Products GmbH.
61
Total
61
Cleared
146d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Method, Nephelometric, Immunoglobulins (g, A, M) Devices (Product Code CFN)
61 devices
About Product Code CFN - Regulatory Context
510(k) Submission Activity
61 total 510(k) submissions under product code CFN since 1977, with 61 receiving FDA clearance (average review time: 146 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
CFN devices are reviewed by the Immunology panel. Browse all Immunology devices →