FDA Product Code CEC: Radioimmunoassay, Free Thyroxine
Leading manufacturers include Roche Diagnostics and Beckman Coulter, Inc..
92
Total
92
Cleared
104d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Radioimmunoassay, Free Thyroxine Devices (Product Code CEC)
92 devices
Cleared
Mar 06, 2024
Access Free T4
Beckman Coulter, Inc.
Chemistry
35d
Cleared
Apr 07, 2023
Elecsys FT4 IV
Roche Diagnostics
Chemistry
414d
About Product Code CEC - Regulatory Context
510(k) Submission Activity
92 total 510(k) submissions under product code CEC since 1977, with 92 receiving FDA clearance (average review time: 104 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
CEC devices are reviewed by the Chemistry panel. Browse all Chemistry devices →