ClearanceBrief
Panels › Clinical Chemistry › Product code CGR · Class 2

Radioimmunoassay, Cortisol

Regulation 862.1205

0510(k)s in 12 months (84 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in CGR

Company510(k)sRecalls
Beckman Coulter, Inc.36
Diagnostic Products Corp.50
Corning Medical & Scientific30
Diagnostic Systems Laboratories, Inc.30
Nichols Institute Diagnostics30
Nuclear Medical Laboratories, Inc.30
Amersham Corp.20
Bd Becton Dickinson Vacutainer Systems Preanalytic20
Bio-Rad Laboratories, Inc.20
Biotecx Laboratories, Inc.20
Decided510(k)Device and applicantCode
Mar 5, 2025K242190Access Cortisol; DxC 500i Clinical Analyzer
Beckman Coulter, Inc.
CGR
Feb 8, 2023K223038Access Cortisol
Beckman Coulter, Inc.
CGR
Apr 13, 2021K202136IDS Cortisol
Immunodiagnostic Systems , Ltd., GB
CGR
Jan 15, 2021K203270IMMULITE/IMMULITE® 1000 Cortisol
Siemens Healthcare Diagnostics Products, Ltd., GB
CGR
Jan 15, 2021K202826IMMULITE® 2000 Cortisol
Siemens Healthcare Diagnostics Products, Ltd., GB
CGR
Dec 20, 2006K062626CORTISOL ELISA
Ibl-Hamburg GmbH, DE
CGR
Jul 3, 2006K060480VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
Ortho-Clinical Diagnostics
CGR
Oct 3, 2005K052359IBL CORTISOL LIA TEST KIT
Lehnus & Associates Consulting
CGR
Feb 9, 2005K050202CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
Beckman Coulter, Inc.
CGR
Dec 9, 2004K042689NICHOLS ADVANTAGE CORTISOL
Nichols Institute Diagnostics
CGR
Jan 29, 2002K010790CORTISOL LIA
Kmi Diagnostics, Inc.
CGR
Feb 5, 1999K984520NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
Nichols Institute Diagnostics
CGR
Dec 29, 1998K983990VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY
Ortho-Clinical Diagnostics, Inc.
CGR
Apr 8, 1997K962208NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
Nichols Institute Diagnostics
CGR
Dec 5, 1995K954733ACCESS CORTISOL ASSAY (MODIFICATION)
Bio-Rad Laboratories, Inc.
CGR
May 5, 1995K945367CIBA CORNING ACS CORTISOL IMMUNOASSAY
Ciba Corning Diagnostics Corp.
CGR
Nov 28, 1994K943427ACE CEDIA CORTISOL ASSAY
Schiapparelli Biosystems, Inc.
CGR
Apr 26, 1994K940221ACCESS CORTISOL REAGENTS
Bio-Rad Laboratories, Inc.
CGR
Sep 27, 1993K931177SYNELISA CORTISOL
Elias U.S.A., Inc.
CGR
May 11, 1993K931409IMMULITE CORTISOL
Diagnostic Products Corp.
CGR
Jul 10, 1992K922676CORTISOL CHEMILUMINESCENCE ASSAY
Nichols Institute
CGR
Mar 2, 1992K914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
Serono-Baker Diagnostics, Inc.
CGR
Jan 31, 1991K905473UBI MAGIWEL CORTISOL QUANTITATIVE
United Biotech, Inc.
CGR
Jan 23, 1991K903975SEROZYME CORTISOL TEST KIT
Serono-Baker Diagnostics, Inc.
CGR
May 2, 1990K900485ENZYMUN TEST(R) CORTISOL
Boehringer Mannheim Corp.
CGR
Apr 3, 1990K901296CEDIA (TM) CORTISOL ASSAY
Microgenics Corp.
CGR
Dec 12, 1989K896451MODIFIED CEDIA(TM) CORTISOL ASSAY
Microgenics Corp.
CGR
Oct 23, 1989K895006MILENIA(TM) CORTISOL (MKCO1,5)
Diagnostic Products Corp.
CGR
Oct 19, 1989K895407CORTISOL CLASP-BEAD EIA KIT
Biotecx Laboratories, Inc.
CGR
Feb 23, 1989K884689DSL 7800 ACTIVE CORTISOL
Diagnostic Systems Laboratories, Inc.
CGR
Mar 24, 1988K880687CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
Amersham Corp.
CGR
Jun 22, 1987K870969CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
Canadian Bioclinical, Ltd., CA
CGR
Jun 17, 1987K872177TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
Nuclear Diagnostics, Inc.
CGR
Sep 25, 1986K862336PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT
Pantex, Div. Bio-Analysis, Inc.
CGR
Aug 19, 1986K862871RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL
Cambridge Medical Technology
CGR
Aug 2, 1985K852939CORTISOL SYSTEM BY EIA
American Bioclinical, Inc.
CGR
Feb 6, 1985K850141ACTIVE CORTISOL DSL 2000-SP
Diagnostic Systems Laboratories, Inc.
CGR
Feb 1, 1985K850008SOPHEIA/MP CORTISOL EIA KIT
Diagnostic Products Corp.
CGR
Sep 28, 1984K843384LEECO CORTISOL-QUANT
Leeco Diagnostics, Inc.
CGR
Sep 17, 1984K843183STRATUS CORTISOL FLUOROMETRIC ENZYME
American Dade
CGR
Sep 14, 1984K842957CORITSOL PREMIX RIA KIT
Biotecx Laboratories, Inc.
CGR
Sep 4, 1984K841641CORNING MAGIC CORTISOL RADIOIMMUNO
Corning Medical & Scientific
CGR
Aug 16, 1984K842455AMER. BIO-SCIENCE LAB CORTISOL REAGENT
American Bio-Science Laboratories
CGR
Aug 16, 1984K842365CORTI-COTE CORTISOL SOLID PHASE RADIO
Bd Becton Dickinson Vacutainer Systems Preanalytic
CGR
Aug 12, 1984K842554IMMPULSE CORTISOL ASSAY REAGENTS
Aktis Corp.
CGR
Mar 30, 1984K840466NML CORTISOL RIA
Nuclear Medical Laboratories, Inc.
CGR
Feb 4, 1984K834219PHASE II CORTISOL KIT
Medical & Scientific Designs, Inc.
CGR
Sep 12, 1983K832638CORTISOL RADIOIMMUNOASSAY KIT
Bioclinical Group
CGR
May 27, 1983K831141EMIT SRD MANUAL CORTISOL ASSAY
Syva Co.
CGR
May 13, 1983K830563CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK
Sorin Biomedica, Fiat, USA, Inc.
CGR

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