CFF · Class II · 21 CFR 866.5510

FDA Product Code CFF: Immunoelectrophoretic, Immunoglobulins, (g, A, M)

Leading manufacturers include Sebia.

29
Total
29
Cleared
141d
Avg days
1979
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Immunoelectrophoretic, Immunoglobulins, (g, A, M) Devices (Product Code CFF)

29 devices
1–24 of 29

About Product Code CFF - Regulatory Context

510(k) Submission Activity

29 total 510(k) submissions under product code CFF since 1979, with 29 receiving FDA clearance (average review time: 141 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

CFF devices are reviewed by the Immunology panel. Browse all Immunology devices →