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JFT — Fluorometric, Cortisol Class II

FDA Device Classification

Classification Details

Product Code
JFT
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
K242505roche diagnosticsElecsys Cortisol IIIJuly 17, 2025
K192788siemens healthcare diagnosticsADVIA Centaur Cortisol (COR)November 25, 2019
K152227roche diagnosticsElecsys Cortisol II, Cortisol II CalSetApril 27, 2016
K142723siemens healthcare diagnosticsADVIA Centaur Cortisol (COR) AssyMarch 31, 2015
K062204seradynARCHITECT CORTISOL ASSAYSeptember 22, 2006
K033731fujirebio diagnosticsAXSYM CORTISOL ASSAYFebruary 20, 2004
K021218roche diagnosticsELECSYS CORTISOL TEST SYSTEMSeptember 9, 2002
K962559ciba corning diagnosticsACS CORTISOL IMMUNOASSAYNovember 5, 1996
K954591tosoh medicsAIA-PACK CORT ASSAYDecember 15, 1995
K934317ciba corning diagnosticsCIDBA CORNING ACS CORTISOL IMMUNOASSAYMay 13, 1994
K930732wallacDELFIA CORTISOL KITJuly 27, 1993
K931031biomerieux vitekVIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENTJuly 27, 1993
K926322bio-rad laboratoriesACCESS(R) CORTISOL REAGENTSMay 26, 1993
K900010kallestad diag, a div. of erbamontNDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATORApril 3, 1990
K895421baxter healthcareCORTISOL TEST SYSTEMDecember 7, 1989
K893954microgenicsCEDIA CORTISOL ASSAYOctober 31, 1989
K863422lkb instrumentsDELFIA(TM) CORTISOL KITSeptember 26, 1986
K854419abbott laboratoriesTDX CORTISOLNovember 25, 1985
K852927abbott laboratoriesTDX CORTISOLAugust 5, 1985
K833932syvaSYVA ADVANCE CORTISOL ASSAYDecember 29, 1983