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

FDA 510(k) Number Applicant Device Name Decision Date
K842554 AKTIS CORP. IMMPULSE CORTISOL ASSAY REAGENTS 08/12/1984
K800538 ALPHA GAMMA LABORATORY GAMMA STICK CORTISOL RIA KIT/STICK KIT 04/24/1980
K842455 AMERICAN BIO-SCIENCE LABORATORIES AMER. BIO-SCIENCE LAB CORTISOL REAGENT 08/16/1984
K852939 AMERICAN BIOCLINICAL, INC. CORTISOL SYSTEM BY EIA 08/02/1985
K843183 AMERICAN DADE STRATUS CORTISOL FLUOROMETRIC ENZYME 09/17/1984
K800700 AMERSHAM CORP. AMERLEX CORTISOL RIA KIT 04/16/1980
K880687 AMERSHAM CORP. CORTISOL ENHANCED LUMINESCENCE ASSAY KIT 03/24/1988
K821931 AMF BIOLOGICAL AND DIAGNOSTICS CO. ZETA-CORT 07/22/1982
K822892 ANTIBODIES INC. CORTISOL RIA KIT 11/01/1982
K802380 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ARIA II 125 I CORTISOL 10/31/1980
K842365 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC CORTI-COTE CORTISOL SOLID PHASE RADIO 08/16/1984
K050202 BECKMAN COULTER, INC. CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS 02/09/2005
K760939 BECKMAN INSTRUMENTS, INC. CORTISOL REAGENT SYSTEM 11/16/1976
K800045 BIO-RAD QUANTIMUNE CORTISOL RIA CORTISOL RADIO- 01/23/1980
K954733 BIO-RAD LABORATORIES, INC. ACCESS CORTISOL ASSAY (MODIFICATION) 12/05/1995
K940221 BIO-RAD LABORATORIES, INC. ACCESS CORTISOL REAGENTS 04/26/1994
K832638 BIOCLINICAL GROUP CORTISOL RADIOIMMUNOASSAY KIT 09/12/1983
K842957 BIOTECX LABORATORIES, INC. CORITSOL PREMIX RIA KIT 09/14/1984
K895407 BIOTECX LABORATORIES, INC. CORTISOL CLASP-BEAD EIA KIT 10/19/1989
K900485 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST(R) CORTISOL 05/02/1990
K830148 CAMBRIDGE MEDICAL TECHNOLOGY CORTISOL KIT 02/09/1983
K862871 CAMBRIDGE MEDICAL TECHNOLOGY RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL 08/19/1986
K870969 CANADIAN BIOCLINICAL, LTD. CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT 06/22/1987
K945367 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS CORTISOL IMMUNOASSAY 05/05/1995
K771117 CLINICAL DIAGNOSTICS, INC. CENTRIA CORTISOL RIA 06/23/1977
K841641 CORNING MEDICAL & SCIENTIFIC CORNING MAGIC CORTISOL RADIOIMMUNO 09/04/1984
K802036 CORNING MEDICAL & SCIENTIFIC CORTISOL125 RADIOIMMUNOASSAY 10/23/1980
K760256 CORNING MEDICAL & SCIENTIFIC TEST SYSTEM, RIA CORTISOL 08/11/1976
K810891 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT CORTISOL RIA KIT 04/14/1981
K931409 DIAGNOSTIC PRODUCTS CORP. IMMULITE CORTISOL 05/11/1993
K895006 DIAGNOSTIC PRODUCTS CORP. MILENIA(TM) CORTISOL (MKCO1,5) 10/23/1989
K822845 DIAGNOSTIC PRODUCTS CORP. SOPHEIA CORTISOL EIA KIT 10/27/1982
K850008 DIAGNOSTIC PRODUCTS CORP. SOPHEIA/MP CORTISOL EIA KIT 02/01/1985
K850141 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE CORTISOL DSL 2000-SP 02/06/1985
K821068 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL 1020 05/05/1982
K884689 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL 7800 ACTIVE CORTISOL 02/23/1989
K790268 E. R. SQUIBB & SONS, INC. CORTISOL RIA KIT 04/04/1979
K820341 E. R. SQUIBB & SONS, INC. CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT 03/04/1982
K931177 ELIAS USA, INC. SYNELISA CORTISOL 09/27/1993
K062626 IBL-HAMBURG GMBH CORTISOL ELISA 12/20/2006
K820074 IMMUNO ASSAY CORP. CORTISOL (RIA) KIT 01/28/1982
K810192 IMMUNOTECH CORP. ENDAB CORTISOL KIT 02/06/1981
K781903 KALLESTAD LABORATORIES, INC. RIA KIT, QUANTITOPE CORTISOL 01/26/1979
K010790 KMI DIAGNOSTICS, INC. CORTISOL LIA 01/29/2002
K843384 LEECO DIAGNOSTICS, INC. LEECO CORTISOL-QUANT 09/28/1984
K052359 Lehnus & Associates Consulting IBL CORTISOL LIA TEST KIT 10/03/2005
K834219 MEDICAL & SCIENTIFIC DESIGNS, INC. PHASE II CORTISOL KIT 02/04/1984
K901296 MICROGENICS CORP. CEDIA (TM) CORTISOL ASSAY 04/03/1990
K896451 MICROGENICS CORP. MODIFIED CEDIA(TM) CORTISOL ASSAY 12/12/1989
K790906 MICROMEDIC SYSTEMS AUTOPAK CORTISOL TEST DELIVERY SYSTEM 06/27/1979
K761346 NEW ENGLAND NUCLEAR RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) 01/07/1977
K782110 NEW ENGLAND NUCLEAR RIA KIT, RIANEN CORTISOL 01/26/1979
K922676 NICHOLS INSTITUTE CORTISOL CHEMILUMINESCENCE ASSAY 07/10/1992
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
K872177 NUCLEAR DIAGNOSTICS, INC. TIPSEP-CORTISOL RIA DIAGNOSTIC KIT 06/17/1987
K791700 NUCLEAR MEDICAL LABORATORIES, INC. CORTI-SHURE 10/01/1979
K810033 NUCLEAR MEDICAL LABORATORIES, INC. CORTI-SHURE 01/21/1981
K840466 NUCLEAR MEDICAL LABORATORIES, INC. NML CORTISOL RIA 03/30/1984
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
K862336 PANTEX, DIV. BIO-ANALYSIS, INC. PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT 09/25/1986
K791835 RADIOASSAY SYSTEMS LABORATORIES, INC. CORALENT COAT 125I CORTISOL RADIOIMM. 09/27/1979
K781730 RADIOASSAY SYSTEMS LABORATORIES, INC. RIA, CORTISOL KIT 11/22/1978
K792036 RADIOIMMUNOASSAY, INC. CORTISOL RADIOIMMUNOASSAY SYSTEM 10/30/1979
K802969 RIA PRODUCTS, INC. CORTISOL 125-I RADIOIMMUNOASSAY KIT 01/02/1981
K943427 SCHIAPPARELLI BIOSYSTEMS, INC. ACE CEDIA CORTISOL ASSAY 11/28/1994
K903975 SERONO-BAKER DIAGNOSTICS, INC. SEROZYME CORTISOL TEST KIT 01/23/1991
K914886 SERONO-BAKER DIAGNOSTICS, INC. SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) 03/02/1992
K830563 SORIN BIOMEDICA, FIAT, USA, INC. CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK 05/13/1983
K800245 SYVA CO. EMIT AUTO CORTISOL ASSAY 03/03/1980
K831141 SYVA CO. EMIT SRD MANUAL CORTISOL ASSAY 05/27/1983
K801203 TECHNIA DIAGNOSTICS LTD. CORTISOL RADIOIMMUNOASSAY KIT 06/09/1980
K792439 TECHNICON INSTRUMENTS CORP. ANALYTE CORTISOL 01/17/1980
K780725 UNION CARBIDE CORP. CENTRIA CORTISOL RIA 06/06/1978
K905473 UNITED BIOTECH, INC. UBI MAGIWEL CORTISOL QUANTITATIVE 01/31/1991
K792243 VENTREX LABORATORIES, INC. CENTRIA CORTISOL RIA TEST SET 12/06/1979
K800594 VENTREX LABORATORIES, INC. VENTRE/SEP CORTISOL RIA 04/04/1980


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