FDA.reportPublic FDA data

510(k) K242190

Device
Access Cortisol; DxC 500i Clinical Analyzer
Applicant
Beckman Coulter, Inc.
510(k) number
K242190
Product code
CGR
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-05
Date received
2024-07-25
Regulation
862.1205
Classification name
Radioimmunoassay, Cortisol
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Mary Beth Tang
Address
250 S. Kraemer Blvd. Brea CA US 92821 92821

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CGR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223038Access CortisolBeckman Coulter, Inc.2023-02-08
K202136IDS CortisolImmunodiagnostic Systems , Ltd.2021-04-13
K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.2021-01-15
K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.2021-01-15
K062626CORTISOL ELISAIbl-Hamburg GmbH2006-12-20
K060480VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLSOrtho-Clinical Diagnostics2006-07-03
K052359IBL CORTISOL LIA TEST KITLehnus & Associates Consulting2005-10-03
K050202CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMSBeckman Coulter, Inc.2005-02-09
K042689NICHOLS ADVANTAGE CORTISOLNichols Institute Diagnostics2004-12-09
K010790CORTISOL LIAKmi Diagnostics, Inc.2002-01-29
K984520NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005Nichols Institute Diagnostics1999-02-05
K983990VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAYOrtho-Clinical Diagnostics, Inc.1998-12-29
K962208NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KITNichols Institute Diagnostics1997-04-08
K954733ACCESS CORTISOL ASSAY (MODIFICATION)Bio-Rad Laboratories, Inc.1995-12-05
K945367CIBA CORNING ACS CORTISOL IMMUNOASSAYCiba Corning Diagnostics Corp.1995-05-05