Product code CGR
- Device name
- Radioimmunoassay, Cortisol
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1205
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242190 | Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. | 2025-03-05 |
| K223038 | Access Cortisol | Beckman Coulter, Inc. | 2023-02-08 |
| K202136 | IDS Cortisol | Immunodiagnostic Systems , Ltd. | 2021-04-13 |
| K202826 | IMMULITE® 2000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |
| K203270 | IMMULITE/IMMULITE® 1000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |
| K062626 | CORTISOL ELISA | Ibl-Hamburg GmbH | 2006-12-20 |
| K060480 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS | Ortho-Clinical Diagnostics | 2006-07-03 |
| K052359 | IBL CORTISOL LIA TEST KIT | Lehnus & Associates Consulting | 2005-10-03 |
| K050202 | CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2005-02-09 |
| K042689 | NICHOLS ADVANTAGE CORTISOL | Nichols Institute Diagnostics | 2004-12-09 |
| K010790 | CORTISOL LIA | Kmi Diagnostics, Inc. | 2002-01-29 |
| K984520 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 | Nichols Institute Diagnostics | 1999-02-05 |
| K983990 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY | Ortho-Clinical Diagnostics, Inc. | 1998-12-29 |
| K962208 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT | Nichols Institute Diagnostics | 1997-04-08 |
| K954733 | ACCESS CORTISOL ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1995-12-05 |
| K945367 | CIBA CORNING ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1995-05-05 |
| K943427 | ACE CEDIA CORTISOL ASSAY | Schiapparelli Biosystems, Inc. | 1994-11-28 |
| K940221 | ACCESS CORTISOL REAGENTS | Bio-Rad Laboratories, Inc. | 1994-04-26 |
| K931177 | SYNELISA CORTISOL | Elias U.S.A., Inc. | 1993-09-27 |
| K931409 | IMMULITE CORTISOL | Diagnostic Products Corp. | 1993-05-11 |
| K922676 | CORTISOL CHEMILUMINESCENCE ASSAY | Nichols Institute | 1992-07-10 |
| K914886 | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) | Serono-Baker Diagnostics, Inc. | 1992-03-02 |
| K905473 | UBI MAGIWEL CORTISOL QUANTITATIVE | United Biotech, Inc. | 1991-01-31 |
| K903975 | SEROZYME CORTISOL TEST KIT | Serono-Baker Diagnostics, Inc. | 1991-01-23 |
| K900485 | ENZYMUN TEST(R) CORTISOL | Boehringer Mannheim Corp. | 1990-05-02 |
| K901296 | CEDIA (TM) CORTISOL ASSAY | Microgenics Corp. | 1990-04-03 |
| K896451 | MODIFIED CEDIA(TM) CORTISOL ASSAY | Microgenics Corp. | 1989-12-12 |
| K895006 | MILENIA(TM) CORTISOL (MKCO1,5) | Diagnostic Products Corp. | 1989-10-23 |
| K895407 | CORTISOL CLASP-BEAD EIA KIT | Biotecx Laboratories, Inc. | 1989-10-19 |
| K884689 | DSL 7800 ACTIVE CORTISOL | Diagnostic Systems Laboratories, Inc. | 1989-02-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850049545242 | AccuDiag ™ | Diagnostic Automation, Inc. | 2024-01-30 |
| 05060169690691 | IDS Cortisol | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2021-04-14 |
| 00816870021317 | Cortisol AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021324 | Cortisol AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022758 | Cortisol AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022765 | Monobind AccuLite Cortisol CLIA Kit - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00630414167404 | IMMULITE 2000 Cortisol Kit Domestic 200T | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2018-01-15 |
| 00630414167411 | IMMULITE 2000 Crotisol Kit Domestic 600T | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2018-01-15 |
| 00817830022610 | Cortisol CT 500 Tube Kit | MP BIOMEDICALS, LLC | 2017-01-09 |
| 00817830022627 | Cortisol CT 1000 Tube Kit | MP BIOMEDICALS, LLC | 2017-01-09 |
| 00817830022306 | ImmuChem Cortisol Coated Tube 125I RIA Kit | MP BIOMEDICALS, LLC | 2016-10-20 |
| 00817830022313 | Corti-Cote 125I RIA Kit | MP BIOMEDICALS, LLC | 2016-10-20 |
| 00630414963761 | IMMULITE®/IMMULITE® 1000 Systems COR Cortisol | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414961194 | IMMULITE® 2000 Systems COR Cortisol | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414961187 | IMMULITE® 2000 Systems COR Cortisol | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414953649 | IMMULITE®/IMMULITE® 1000 Systems COR Cortisol Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 15099590231118 | Access Cortisol | Beckman Coulter, Inc. | 2016-09-09 |
| 10758750008377 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |