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CJM — Radioimmunoassay, Aldosterone Class II

FDA Device Classification

Classification Details

Product Code
CJM
Device Class
Class II
Regulation Number
862.1045
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K142994immunodiagnostic systemsIDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone April 21, 2015
K130321diasorinLIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRApril 9, 2013
K050784nichols institute diagnosticsNICHOLS ADVANTAGE ALDOSTERONE ASSAYJune 1, 2005
K032188nichols institute diagnosticsNICHOLS ADVANTAGE ALDOSTERONE ASSAYJuly 31, 2003
K943397diagnostic systems laboratoriesDSL ACTIVE ALDOSTERONE RIA (DSL 8600)February 13, 1995
K921205diagnostic systems laboratoriesDSL ACTIVE ALDOSTERONE (DSL 8600)July 10, 1992
K862204radioassay systems laboratoriesRSL (125I) ALDOSTERONE KITSeptember 25, 1986
K834428serono laboratoriesALDOSTERONE RADIOIMMUNOASSAY TEST KITMarch 2, 1984
K831178diagnostic productsCOAT-A-COUNT NO-EXTRACTION ALDOSTERONEMay 27, 1983
K800775sorin biomedica, fiat, usaALDOCTK-125April 21, 1980
K781504abbott laboratories125I-ALDOSTERONE RIA DIAG. KITNovember 22, 1978
K771526diagnostic products125 I ALDOSTERONE RIA KITAugust 25, 1977