Radioimmunoassay, Cortisol

FDA product code CGR · 84 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1205
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-11 – 2025-03-05

CGR 2025-03-05

Access Cortisol; DxC 500i Clinical Analyzer

Applicant Beckman Coulter, Inc.

K number K242190

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CGR 2023-02-08

Access Cortisol

Applicant Beckman Coulter, Inc.

K number K223038

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CGR 2021-04-13

IDS Cortisol

Applicant Immunodiagnostic Systems , Ltd.

K number K202136

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CGR 2021-01-15

IMMULITE/IMMULITE® 1000 Cortisol

Applicant Siemens Healthcare Diagnostics Products, Ltd.

K number K203270

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CGR 2021-01-15

IMMULITE® 2000 Cortisol

Applicant Siemens Healthcare Diagnostics Products, Ltd.

K number K202826

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CGR 2006-12-20

CORTISOL ELISA

Applicant Ibl-Hamburg GmbH

K number K062626

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CGR 2006-07-03

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS

Applicant Ortho-Clinical Diagnostics

K number K060480

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CGR 2005-10-03

IBL CORTISOL LIA TEST KIT

Applicant Lehnus & Associates Consulting

K number K052359

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CGR 2005-02-09

CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS

Applicant Beckman Coulter, Inc.

K number K050202

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CGR 2004-12-09

NICHOLS ADVANTAGE CORTISOL

Applicant Nichols Institute Diagnostics

K number K042689

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CGR 2002-01-29

CORTISOL LIA

Applicant Kmi Diagnostics, Inc.

K number K010790

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CGR 1999-02-05

NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005

Applicant Nichols Institute Diagnostics

K number K984520

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CGR 1998-12-29

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY

Applicant Ortho-Clinical Diagnostics, Inc.

K number K983990

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CGR 1997-04-08

NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT

Applicant Nichols Institute Diagnostics

K number K962208

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CGR 1995-12-05

ACCESS CORTISOL ASSAY (MODIFICATION)

Applicant Bio-Rad Laboratories, Inc.

K number K954733

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CGR 1995-05-05

CIBA CORNING ACS CORTISOL IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K945367

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CGR 1994-11-28

ACE CEDIA CORTISOL ASSAY

Applicant Schiapparelli Biosystems, Inc.

K number K943427

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CGR 1994-04-26

ACCESS CORTISOL REAGENTS

Applicant Bio-Rad Laboratories, Inc.

K number K940221

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CGR 1993-09-27

SYNELISA CORTISOL

Applicant Elias U.S.A., Inc.

K number K931177

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CGR 1993-05-11

IMMULITE CORTISOL

Applicant Diagnostic Products Corp.

K number K931409

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CGR 1992-07-10

CORTISOL CHEMILUMINESCENCE ASSAY

Applicant Nichols Institute

K number K922676

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CGR 1992-03-02

SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)

Applicant Serono-Baker Diagnostics, Inc.

K number K914886

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CGR 1991-01-31

UBI MAGIWEL CORTISOL QUANTITATIVE

Applicant United Biotech, Inc.

K number K905473

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CGR 1991-01-23

SEROZYME CORTISOL TEST KIT

Applicant Serono-Baker Diagnostics, Inc.

K number K903975

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CGR 1990-05-02

ENZYMUN TEST(R) CORTISOL

Applicant Boehringer Mannheim Corp.

K number K900485

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CGR 1990-04-03

CEDIA (TM) CORTISOL ASSAY

Applicant Microgenics Corp.

K number K901296

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CGR 1989-12-12

MODIFIED CEDIA(TM) CORTISOL ASSAY

Applicant Microgenics Corp.

K number K896451

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CGR 1989-10-23

MILENIA(TM) CORTISOL (MKCO1,5)

Applicant Diagnostic Products Corp.

K number K895006

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CGR 1989-10-19

CORTISOL CLASP-BEAD EIA KIT

Applicant Biotecx Laboratories, Inc.

K number K895407

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CGR 1989-02-23

DSL 7800 ACTIVE CORTISOL

Applicant Diagnostic Systems Laboratories, Inc.

K number K884689

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CGR 1988-03-24

CORTISOL ENHANCED LUMINESCENCE ASSAY KIT

Applicant Amersham Corp.

K number K880687

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CGR 1987-06-22

CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

Applicant Canadian Bioclinical, Ltd.

K number K870969

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CGR 1987-06-17

TIPSEP-CORTISOL RIA DIAGNOSTIC KIT

Applicant Nuclear Diagnostics, Inc.

K number K872177

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CGR 1986-09-25

PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT

Applicant Pantex, Div. Bio-Analysis, Inc.

K number K862336

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CGR 1986-08-19

RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL

Applicant Cambridge Medical Technology

K number K862871

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CGR 1985-08-02

CORTISOL SYSTEM BY EIA

Applicant American Bioclinical, Inc.

K number K852939

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CGR 1985-02-06

ACTIVE CORTISOL DSL 2000-SP

Applicant Diagnostic Systems Laboratories, Inc.

K number K850141

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CGR 1985-02-01

SOPHEIA/MP CORTISOL EIA KIT

Applicant Diagnostic Products Corp.

K number K850008

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CGR 1984-09-28

LEECO CORTISOL-QUANT

Applicant Leeco Diagnostics, Inc.

K number K843384

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CGR 1984-09-17

STRATUS CORTISOL FLUOROMETRIC ENZYME

Applicant American Dade

K number K843183

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CGR 1984-09-14

CORITSOL PREMIX RIA KIT

Applicant Biotecx Laboratories, Inc.

K number K842957

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CGR 1984-09-04

CORNING MAGIC CORTISOL RADIOIMMUNO

Applicant Corning Medical & Scientific

K number K841641

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CGR 1984-08-16

AMER. BIO-SCIENCE LAB CORTISOL REAGENT

Applicant American Bio-Science Laboratories

K number K842455

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CGR 1984-08-16

CORTI-COTE CORTISOL SOLID PHASE RADIO

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K842365

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CGR 1984-08-12

IMMPULSE CORTISOL ASSAY REAGENTS

Applicant Aktis Corp.

K number K842554

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CGR 1984-03-30

NML CORTISOL RIA

Applicant Nuclear Medical Laboratories, Inc.

K number K840466

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CGR 1984-02-04

PHASE II CORTISOL KIT

Applicant Medical & Scientific Designs, Inc.

K number K834219

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CGR 1983-09-12

CORTISOL RADIOIMMUNOASSAY KIT

Applicant Bioclinical Group

K number K832638

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CGR 1983-05-27

EMIT SRD MANUAL CORTISOL ASSAY

Applicant Syva Co.

K number K831141

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CGR 1983-05-13

CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK

Applicant Sorin Biomedica, Fiat, USA, Inc.

K number K830563

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CGR 1983-02-09

CORTISOL KIT

Applicant Cambridge Medical Technology

K number K830148

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CGR 1982-11-01

CORTISOL RIA KIT

Applicant Antibodies, Inc.

K number K822892

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CGR 1982-10-27

SOPHEIA CORTISOL EIA KIT

Applicant Diagnostic Products Corp.

K number K822845

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CGR 1982-07-22

ZETA-CORT

Applicant Amf Biological and Diagnostics Co.

K number K821931

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CGR 1982-05-05

DSL 1020

Applicant Diagnostic Systems Laboratories, Inc.

K number K821068

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CGR 1982-03-04

CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT

Applicant E. R. Squibb & Sons, Inc.

K number K820341

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CGR 1982-01-28

CORTISOL (RIA) KIT

Applicant Immuno Assay Corp.

K number K820074

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CGR 1981-04-14

COAT-A-COUNT CORTISOL RIA KIT

Applicant Diagnostic Products Corp.

K number K810891

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CGR 1981-02-06

ENDAB CORTISOL KIT

Applicant Immunotech Corp.

K number K810192

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CGR 1981-01-21

CORTI-SHURE

Applicant Nuclear Medical Laboratories, Inc.

K number K810033

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CGR 1981-01-02

CORTISOL 125-I RADIOIMMUNOASSAY KIT

Applicant Ria Products, Inc.

K number K802969

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CGR 1980-10-31

ARIA II 125 I CORTISOL

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K802380

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CGR 1980-10-23

CORTISOL125 RADIOIMMUNOASSAY

Applicant Corning Medical & Scientific

K number K802036

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CGR 1980-06-09

CORTISOL RADIOIMMUNOASSAY KIT

Applicant Technia Diagnostics , Ltd.

K number K801203

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CGR 1980-04-24

GAMMA STICK CORTISOL RIA KIT/STICK KIT

Applicant Alpha Gamma Laboratory

K number K800538

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CGR 1980-04-16

AMERLEX CORTISOL RIA KIT

Applicant Amersham Corp.

K number K800700

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CGR 1980-04-04

VENTRE/SEP CORTISOL RIA

Applicant Ventrex Laboratories, Inc.

K number K800594

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CGR 1980-03-03

EMIT AUTO CORTISOL ASSAY

Applicant Syva Co.

K number K800245

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CGR 1980-01-23

QUANTIMUNE CORTISOL RIA CORTISOL RADIO-

Applicant Bio-Rad

K number K800045

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CGR 1980-01-17

ANALYTE CORTISOL

Applicant Technicon Instruments Corp.

K number K792439

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CGR 1979-12-06

CENTRIA CORTISOL RIA TEST SET

Applicant Ventrex Laboratories, Inc.

K number K792243

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CGR 1979-10-30

CORTISOL RADIOIMMUNOASSAY SYSTEM

Applicant Radioimmunoassay, Inc.

K number K792036

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CGR 1979-10-01

CORTI-SHURE

Applicant Nuclear Medical Laboratories, Inc.

K number K791700

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CGR 1979-09-27

CORALENT COAT 125I CORTISOL RADIOIMM.

Applicant Radioassay Systems Laboratories, Inc.

K number K791835

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CGR 1979-06-27

AUTOPAK CORTISOL TEST DELIVERY SYSTEM

Applicant Micromedic Systems

K number K790906

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CGR 1979-04-04

CORTISOL RIA KIT

Applicant E. R. Squibb & Sons, Inc.

K number K790268

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CGR 1979-01-26

RIA KIT, RIANEN CORTISOL

Applicant New England Nuclear

K number K782110

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CGR 1979-01-26

RIA KIT, QUANTITOPE CORTISOL

Applicant Kallestad Laboratories, Inc.

K number K781903

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CGR 1978-11-22

RIA, CORTISOL KIT

Applicant Radioassay Systems Laboratories, Inc.

K number K781730

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CGR 1978-06-06

CENTRIA CORTISOL RIA

Applicant Union Carbide Corp.

K number K780725

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CGR 1977-06-23

CENTRIA CORTISOL RIA

Applicant Clinical Diagnostics, Inc.

K number K771117

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CGR 1977-01-07

RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)

Applicant New England Nuclear

K number K761346

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CGR 1976-11-16

CORTISOL REAGENT SYSTEM

Applicant Beckman Instruments, Inc.

K number K760939

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CGR 1976-08-11

TEST SYSTEM, RIA CORTISOL

Applicant Corning Medical & Scientific

K number K760256

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