CKG · Class II · 21 CFR 862.1025

FDA Product Code CKG: Radioimmunoassay, Acth

Leading manufacturers include Immunodiagnostic Systems Limited.

30
Total
30
Cleared
97d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Radioimmunoassay, Acth Devices (Product Code CKG)

30 devices
1–24 of 30

About Product Code CKG - Regulatory Context

510(k) Submission Activity

30 total 510(k) submissions under product code CKG since 1981, with 30 receiving FDA clearance (average review time: 97 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

CKG devices are reviewed by the Chemistry panel. Browse all Chemistry devices →