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CGR — Radioimmunoassay, Cortisol Class II

FDA Device Classification

Classification Details

Product Code
CGR
Device Class
Class II
Regulation Number
862.1205
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242190beckman coulterAccess Cortisol; DxC 500i Clinical AnalyzerMarch 5, 2025
K223038beckman coulterAccess CortisolFebruary 8, 2023
K202136immunodiagnostic systemsIDS CortisolApril 13, 2021
K202826siemens healthcare diagnostics productsIMMULITE® 2000 CortisolJanuary 15, 2021
K203270siemens healthcare diagnostics productsIMMULITE/IMMULITE® 1000 CortisolJanuary 15, 2021
K062626ibl-hamburgCORTISOL ELISADecember 20, 2006
K060480ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABJuly 3, 2006
K052359lehnus and associates consultingIBL CORTISOL LIA TEST KITOctober 3, 2005
K050202beckman coulterCORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMSFebruary 9, 2005
K042689nichols institute diagnosticsNICHOLS ADVANTAGE CORTISOLDecember 9, 2004
K010790kmi diagnosticsCORTISOL LIAJanuary 29, 2002
K984520nichols institute diagnosticsNICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005February 5, 1999
K983990ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAYDecember 29, 1998
K962208nichols institute diagnosticsNICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KITApril 8, 1997
K954733bio-rad laboratoriesACCESS CORTISOL ASSAY (MODIFICATION)December 5, 1995
K945367ciba corning diagnosticsCIBA CORNING ACS CORTISOL IMMUNOASSAYMay 5, 1995
K943427schiapparelli biosystemsACE CEDIA CORTISOL ASSAYNovember 28, 1994
K940221bio-rad laboratoriesACCESS CORTISOL REAGENTSApril 26, 1994
K931177elias u.s.aSYNELISA CORTISOLSeptember 27, 1993
K931409diagnostic productsIMMULITE CORTISOLMay 11, 1993