CKG · Class II · 21 CFR 862.1025

FDA Product Code CKG: Radioimmunoassay, Acth

Leading manufacturers include Nichols Institute Diagnostics, Diagnostic Systems Laboratories, Inc. and Syncor Intl. 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
1–24 of 30
Cleared Aug 18, 2023
IDS ACTH II
K223867
Immunodiagnostic Systems Limited
Chemistry · 238d
Cleared Dec 01, 2011
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
K111335
Tosoh Bioscience, Inc.
Chemistry · 203d
Cleared May 03, 2006
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
K060585
Roche Diagnostics Corp.
Chemistry · 57d
Cleared May 20, 2005
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
K050748
Scantibodies Laboratory, Inc.
Chemistry · 59d
Cleared Jun 03, 2002
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
K021032
Scantibodies Laboratory, Inc.
Chemistry · 66d
Cleared Aug 19, 1998
SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
K982608
Sangui Biotech, Inc.
Chemistry · 23d
Cleared Dec 24, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
K962601
Nichols Institute Diagnostics
Chemistry · 175d
Cleared Oct 18, 1996
MICRO HAEMATOCRIT CENTRIFUGE
K960491
Hawksley & Sons , Ltd.
Hematology · 260d
Cleared Feb 16, 1996
IMMULITE ACTH
K960066
Diagnostic Products Corp.
Chemistry · 42d
Cleared Aug 02, 1994
INCSTAR ACTH IRMA
K940271
Incstar Corp.
Chemistry · 193d
Cleared Mar 01, 1990
MODIFIED DSL-2300 ACTH RIA
K900147
Diagnostic Systems Laboratories, Inc.
Chemistry · 49d
Cleared Aug 30, 1988
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
K882741
Nichols Institute Diagnostics
Chemistry · 60d
Cleared Mar 21, 1985
ACTH II BY RADIOIMMUNOASSAY
K850882
Immuno Nuclear Corp.
Chemistry · 17d
Cleared Nov 27, 1984
ACTH RIA
K844181
Syncor Intl. Corp.
Chemistry · 32d
Cleared Aug 15, 1984
ACTH NORMAL RANGE
K842249
Diagnostic Systems Laboratories, Inc.
Chemistry · 70d
Cleared Mar 23, 1984
DPC ACTH KIT
K840018
Diagnostic Products Corp.
Chemistry · 78d
Cleared Jan 30, 1984
ACTH RIA
K833849
Syncor Intl. Corp.
Chemistry · 87d
Cleared Jan 11, 1984
ADRENOCOR TICOTROPIC HORMONE RADIOIMM
K833471
Nichols Institute Diagnostics
Chemistry · 97d
Cleared Apr 27, 1983
ACTH RIA SYSTEM-DSI 2300
K830893
Diagnostic Systems Laboratories, Inc.
Chemistry · 37d
Cleared Oct 18, 1982
SERAGAN ACTH125 I-RIA KIT
K822115
Seragen Diagnostics, Inc.
Chemistry · 91d
Cleared Jun 25, 1981
ACTH RADIOIMMUNOASSAY KIT
K811565
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.