FDA 510(k) Applications for Medical Device Product Code "CJM"
(Radioimmunoassay, Aldosterone)

FDA 510(k) Number Applicant Device Name Decision Date
K781504 ABBOTT LABORATORIES 125I-ALDOSTERONE RIA DIAG. KIT 11/22/1978
K771526 DIAGNOSTIC PRODUCTS CORP. 125 I ALDOSTERONE RIA KIT 08/25/1977
K831178 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT NO-EXTRACTION ALDOSTERONE 05/27/1983
K921205 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE ALDOSTERONE (DSL 8600) 07/10/1992
K943397 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE ALDOSTERONE RIA (DSL 8600) 02/13/1995
K130321 DIASORIN LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS 04/09/2013
K142994 IMMUNODIAGNOSTIC SYSTEMS LTD. IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers 04/21/2015
K032188 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE ALDOSTERONE ASSAY 07/31/2003
K050784 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE ALDOSTERONE ASSAY 06/01/2005
K862204 RADIOASSAY SYSTEMS LABORATORIES, INC. RSL (125I) ALDOSTERONE KIT 09/25/1986
K834428 SERONO LABORATORIES, INC. ALDOSTERONE RADIOIMMUNOASSAY TEST KIT 03/02/1984
K800775 SORIN BIOMEDICA, FIAT, USA, INC. ALDOCTK-125 04/21/1980


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