CJM · Class II · 21 CFR 862.1045

FDA Product Code CJM: Radioimmunoassay, Aldosterone

Leading manufacturers include Diagnostic Products Corp., Diagnostic Systems Laboratories, Inc. and Nichols Institute Diagnostics.

12
Total
12
Cleared
84d
Avg days
1977
Since

FDA 510(k) Cleared Radioimmunoassay, Aldosterone Devices (Product Code CJM)

12 devices
1–12 of 12
Cleared Apr 21, 2015
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
K142994
Immunodiagnostic Systems , Ltd.
Chemistry · 187d
Cleared Apr 09, 2013
LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS
K130321
Diasorin
Chemistry · 60d
Cleared Jun 01, 2005
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K050784
Nichols Institute Diagnostics
Chemistry · 65d
Cleared Jul 31, 2003
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K032188
Nichols Institute Diagnostics
Chemistry · 14d
Cleared Feb 13, 1995
DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
K943397
Diagnostic Systems Laboratories, Inc.
Chemistry · 214d
Cleared Jul 10, 1992
DSL ACTIVE ALDOSTERONE (DSL 8600)
K921205
Diagnostic Systems Laboratories, Inc.
Chemistry · 120d
Cleared May 27, 1983
COAT-A-COUNT NO-EXTRACTION ALDOSTERONE
K831178
Diagnostic Products Corp.
Chemistry · 46d
Cleared Apr 21, 1980
ALDOCTK-125
K800775
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 14d
Cleared Nov 22, 1978
125I-ALDOSTERONE RIA DIAG. KIT
K781504
Abbott Laboratories
Chemistry · 84d
Cleared Aug 25, 1977
125 I ALDOSTERONE RIA KIT
K771526
Diagnostic Products Corp.
Toxicology · 17d

About Product Code CJM - Regulatory Context