FDA 510(k) Applications for Medical Device Product Code "JFT"
(Fluorometric, Cortisol)

FDA 510(k) Number Applicant Device Name Decision Date
K962559 CIBA CORNING DIAGNOSTICS CORP. ACS CORTISOL IMMUNOASSAY 11/05/1996
K033731 FUJIREBIO DIAGNOSTICS, INC. AXSYM CORTISOL ASSAY 02/20/2004
K152227 ROCHE DIAGNOSTICS Elecsys Cortisol II, Cortisol II CalSet 04/27/2016
K021218 ROCHE DIAGNOSTICS CORP. ELECSYS CORTISOL TEST SYSTEM 09/09/2002
K062204 SERADYN INC. ARCHITECT CORTISOL ASSAY 09/22/2006
K142723 Siemens Healthcare Diagnostics Inc. ADVIA Centaur Cortisol (COR) Assy 03/31/2015
K192788 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Cortisol (COR) 11/25/2019


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