FDA 510(k) Applications for Medical Device Product Code: CGR (Radioimmunoassay, Cortisol)

FDA 510(k) Applications for Medical Device Product Code "CGR"
(Radioimmunoassay, Cortisol)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K223038	Beckman Coulter, Inc	Access Cortisol	02/08/2023
K050202	BECKMAN COULTER, INC.	CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS	02/09/2005
K062626	IBL-HAMBURG GMBH	CORTISOL ELISA	12/20/2006
K202136	Immunodiagnostic Systems Ltd.	IDS Cortisol	04/13/2021
K010790	KMI DIAGNOSTICS, INC.	CORTISOL LIA	01/29/2002
K052359	Lehnus & Associates Consulting	IBL CORTISOL LIA TEST KIT	10/03/2005
K984520	NICHOLS INSTITUTE DIAGNOSTICS	NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005	02/05/1999
K962208	NICHOLS INSTITUTE DIAGNOSTICS	NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT	04/08/1997
K042689	NICHOLS INSTITUTE DIAGNOSTICS	NICHOLS ADVANTAGE CORTISOL	12/09/2004
K060480	ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS	07/03/2006
K983990	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY	12/29/1998
K202826	Siemens Healthcare Diagnostics Products Ltd.	IMMULITE« 2000 Cortisol	01/15/2021
K203270	Siemens Healthcare Diagnostics Products Ltd.	IMMULITE/IMMULITE« 1000 Cortisol	01/15/2021