FDA Product Code CKG: Radioimmunoassay, Acth
Leading manufacturers include Diagnostic Products Corp., Roche Diagnostics Corp. and 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
Cleared
Aug 18, 2023
IDS ACTH II
Immunodiagnostic Systems Limited
Chemistry
238d
Cleared
May 03, 2006
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
Roche Diagnostics Corp.
Chemistry
57d
Cleared
Feb 16, 1996
IMMULITE ACTH
Diagnostic Products Corp.
Chemistry
42d
Cleared
Mar 23, 1984
DPC ACTH KIT
Diagnostic Products Corp.
Chemistry
78d
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.