FDA Product Code CKG: Radioimmunoassay, Acth
Leading manufacturers include Diagnostic Systems Laboratories, Inc., Nichols Institute Diagnostics and Immuno Nuclear Corp..
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
Dec 24, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
Nichols Institute Diagnostics
Chemistry
175d
Cleared
Feb 16, 1996
IMMULITE ACTH
Diagnostic Products Corp.
Chemistry
42d
Cleared
Aug 02, 1994
INCSTAR ACTH IRMA
Incstar Corp.
Chemistry
193d
Cleared
Mar 01, 1990
MODIFIED DSL-2300 ACTH RIA
Diagnostic Systems Laboratories, Inc.
Chemistry
49d
Cleared
Aug 30, 1988
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
Nichols Institute Diagnostics
Chemistry
60d
Cleared
Mar 21, 1985
ACTH II BY RADIOIMMUNOASSAY
Immuno Nuclear Corp.
Chemistry
17d
Cleared
Nov 27, 1984
ACTH RIA
Syncor Intl. Corp.
Chemistry
32d
Cleared
Aug 15, 1984
ACTH NORMAL RANGE
Diagnostic Systems Laboratories, Inc.
Chemistry
70d
Cleared
Mar 23, 1984
DPC ACTH KIT
Diagnostic Products Corp.
Chemistry
78d
Cleared
Jan 30, 1984
ACTH RIA
Syncor Intl. Corp.
Chemistry
87d
Cleared
Jan 11, 1984
ADRENOCOR TICOTROPIC HORMONE RADIOIMM
Nichols Institute Diagnostics
Chemistry
97d
Cleared
Apr 27, 1983
ACTH RIA SYSTEM-DSI 2300
Diagnostic Systems Laboratories, Inc.
Chemistry
37d
Cleared
Jun 25, 1981
ACTH RADIOIMMUNOASSAY KIT
Immuno Nuclear Corp.
Chemistry
21d
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.