Panels › Clinical Chemistry › Product code JFT · Class 2

Fluorometric, Cortisol

Regulation 862.1205

0510(k)s in 12 months (20 all time)

0recalls in 12 months (5 all time)

5recalls that name a 510(k)

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Top companies in JFT

Company	510(k)s	Recalls
Siemens Healthcare Diagnostics, Inc.	2	3
Roche Diagnostics	3	0
Abbott Laboratories	2	0
Ciba Corning Diagnostics Corp.	2	0
Abbott Laboratories HPD/ADD/GPRD	0	1
Baxter Healthcare Corp	1	0
Bio-Rad Laboratories, Inc.	1	0
Biomerieux Vitek, Inc.	1	0
Fujirebio Diagnostics,Inc.	1	0
Kallestad Diag, A Div. of Erbamont, Inc.	1	0

Decided	510(k)	Device and applicant	Code
Jul 17, 2025	K242505	Elecsys Cortisol III Roche Diagnostics	JFT
Nov 25, 2019	K192788	ADVIA Centaur Cortisol (COR) Siemens Healthcare Diagnostics, Inc.	JFT
Apr 27, 2016	K152227	Elecsys Cortisol II, Cortisol II CalSet Roche Diagnostics	JFT
Mar 31, 2015	K142723	ADVIA Centaur Cortisol (COR) Assy Siemens Healthcare Diagnostics, Inc.	JFT
Sep 22, 2006	K062204	ARCHITECT CORTISOL ASSAY Seradyn, Inc.	JFT
Feb 20, 2004	K033731	AXSYM CORTISOL ASSAY Fujirebio Diagnostics,Inc.	JFT
Sep 9, 2002	K021218	ELECSYS CORTISOL TEST SYSTEM Roche Diagnostics Corp.	JFT
Nov 5, 1996	K962559	ACS CORTISOL IMMUNOASSAY Ciba Corning Diagnostics Corp.	JFT
Dec 15, 1995	K954591	AIA-PACK CORT ASSAY Tosoh Medics, Inc.	JFT
May 13, 1994	K934317	CIDBA CORNING ACS CORTISOL IMMUNOASSAY Ciba Corning Diagnostics Corp.	JFT
Jul 27, 1993	K931031	VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT Biomerieux Vitek, Inc.	JFT
Jul 27, 1993	K930732	DELFIA CORTISOL KIT Wallac OY, FI	JFT
May 26, 1993	K926322	ACCESS(R) CORTISOL REAGENTS Bio-Rad Laboratories, Inc.	JFT
Apr 3, 1990	K900010	NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR Kallestad Diag, A Div. of Erbamont, Inc.	JFT
Dec 7, 1989	K895421	CORTISOL TEST SYSTEM Baxter Healthcare Corp	JFT
Oct 31, 1989	K893954	CEDIA CORTISOL ASSAY Microgenics Corp.	JFT
Sep 26, 1986	K863422	DELFIA(TM) CORTISOL KIT Lkb Instruments, Inc.	JFT
Nov 25, 1985	K854419	TDX CORTISOL Abbott Laboratories	JFT
Aug 5, 1985	K852927	TDX CORTISOL Abbott Laboratories	JFT
Dec 29, 1983	K833932	SYVA ADVANCE CORTISOL ASSAY Syva Co.	JFT

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