FDA Product Code
FDA Product Code CGR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1205
510(k) Clearances — 84 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242190 | Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. | 2025-03-05 | Traditional | PDF ↗ |
| K223038 | Access Cortisol | Beckman Coulter, Inc. | 2023-02-08 | Traditional | PDF ↗ |
| K202136 | IDS Cortisol | Immunodiagnostic Systems , Ltd. | 2021-04-13 | Traditional | PDF ↗ |
| K202826 | IMMULITE® 2000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 | Traditional | PDF ↗ |
| K203270 | IMMULITE/IMMULITE® 1000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 | Traditional | PDF ↗ |
| K062626 | CORTISOL ELISA | Ibl-Hamburg GmbH | 2006-12-20 | Traditional | PDF ↗ |
| K060480 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS | Ortho-Clinical Diagnostics | 2006-07-03 | Traditional | PDF ↗ |
| K052359 | IBL CORTISOL LIA TEST KIT | Lehnus & Associates Consulting | 2005-10-03 | Traditional | PDF ↗ |
| K050202 | CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2005-02-09 | Special | PDF ↗ |
| K042689 | NICHOLS ADVANTAGE CORTISOL | Nichols Institute Diagnostics | 2004-12-09 | Traditional | PDF ↗ |
| K010790 | CORTISOL LIA | Kmi Diagnostics, Inc. | 2002-01-29 | Traditional | PDF ↗ |
| K984520 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 | Nichols Institute Diagnostics | 1999-02-05 | Traditional | PDF ↗ |
| K983990 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY | Ortho-Clinical Diagnostics, Inc. | 1998-12-29 | Traditional | PDF ↗ |
| K962208 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT | Nichols Institute Diagnostics | 1997-04-08 | Traditional | PDF ↗ |
| K954733 | ACCESS CORTISOL ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1995-12-05 | Traditional | PDF ↗ |
| K945367 | CIBA CORNING ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1995-05-05 | Traditional | PDF ↗ |
| K943427 | ACE CEDIA CORTISOL ASSAY | Schiapparelli Biosystems, Inc. | 1994-11-28 | Traditional | PDF ↗ |
| K940221 | ACCESS CORTISOL REAGENTS | Bio-Rad Laboratories, Inc. | 1994-04-26 | Traditional | PDF ↗ |
| K931177 | SYNELISA CORTISOL | Elias U.S.A., Inc. | 1993-09-27 | Traditional | PDF ↗ |
| K931409 | IMMULITE CORTISOL | Diagnostic Products Corp. | 1993-05-11 | Traditional | PDF ↗ |
| K922676 | CORTISOL CHEMILUMINESCENCE ASSAY | Nichols Institute | 1992-07-10 | Traditional | PDF ↗ |
| K914886 | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) | Serono-Baker Diagnostics, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K905473 | UBI MAGIWEL CORTISOL QUANTITATIVE | United Biotech, Inc. | 1991-01-31 | Traditional | PDF ↗ |
| K903975 | SEROZYME CORTISOL TEST KIT | Serono-Baker Diagnostics, Inc. | 1991-01-23 | Traditional | PDF ↗ |
| K900485 | ENZYMUN TEST(R) CORTISOL | Boehringer Mannheim Corp. | 1990-05-02 | Traditional | PDF ↗ |
| K901296 | CEDIA (TM) CORTISOL ASSAY | Microgenics Corp. | 1990-04-03 | Traditional | PDF ↗ |
| K896451 | MODIFIED CEDIA(TM) CORTISOL ASSAY | Microgenics Corp. | 1989-12-12 | Traditional | PDF ↗ |
| K895006 | MILENIA(TM) CORTISOL (MKCO1,5) | Diagnostic Products Corp. | 1989-10-23 | Traditional | PDF ↗ |
| K895407 | CORTISOL CLASP-BEAD EIA KIT | Biotecx Laboratories, Inc. | 1989-10-19 | Traditional | PDF ↗ |
| K884689 | DSL 7800 ACTIVE CORTISOL | Diagnostic Systems Laboratories, Inc. | 1989-02-23 | Traditional | PDF ↗ |
| K880687 | CORTISOL ENHANCED LUMINESCENCE ASSAY KIT | Amersham Corp. | 1988-03-24 | Traditional | PDF ↗ |
| K870969 | CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT | Canadian Bioclinical, Ltd. | 1987-06-22 | Traditional | PDF ↗ |
| K872177 | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT | Nuclear Diagnostics, Inc. | 1987-06-17 | Traditional | PDF ↗ |
| K862336 | PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | 1986-09-25 | Traditional | PDF ↗ |
| K862871 | RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL | Cambridge Medical Technology | 1986-08-19 | Traditional | PDF ↗ |
| K852939 | CORTISOL SYSTEM BY EIA | American Bioclinical, Inc. | 1985-08-02 | Traditional | PDF ↗ |
| K850141 | ACTIVE CORTISOL DSL 2000-SP | Diagnostic Systems Laboratories, Inc. | 1985-02-06 | Traditional | PDF ↗ |
| K850008 | SOPHEIA/MP CORTISOL EIA KIT | Diagnostic Products Corp. | 1985-02-01 | Traditional | PDF ↗ |
| K843384 | LEECO CORTISOL-QUANT | Leeco Diagnostics, Inc. | 1984-09-28 | Traditional | PDF ↗ |
| K843183 | STRATUS CORTISOL FLUOROMETRIC ENZYME | American Dade | 1984-09-17 | Traditional | PDF ↗ |
| K842957 | CORITSOL PREMIX RIA KIT | Biotecx Laboratories, Inc. | 1984-09-14 | Traditional | PDF ↗ |
| K841641 | CORNING MAGIC CORTISOL RADIOIMMUNO | Corning Medical & Scientific | 1984-09-04 | Traditional | PDF ↗ |
| K842365 | CORTI-COTE CORTISOL SOLID PHASE RADIO | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-08-16 | Traditional | PDF ↗ |
| K842455 | AMER. BIO-SCIENCE LAB CORTISOL REAGENT | American Bio-Science Laboratories | 1984-08-16 | Traditional | PDF ↗ |
| K842554 | IMMPULSE CORTISOL ASSAY REAGENTS | Aktis Corp. | 1984-08-12 | Traditional | PDF ↗ |
| K840466 | NML CORTISOL RIA | Nuclear Medical Laboratories, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K834219 | PHASE II CORTISOL KIT | Medical & Scientific Designs, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K832638 | CORTISOL RADIOIMMUNOASSAY KIT | Bioclinical Group | 1983-09-12 | Traditional | PDF ↗ |
| K831141 | EMIT SRD MANUAL CORTISOL ASSAY | Syva Co. | 1983-05-27 | Traditional | PDF ↗ |
| K830563 | CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK | Sorin Biomedica, Fiat, USA, Inc. | 1983-05-13 | Traditional | PDF ↗ |
| K830148 | CORTISOL KIT | Cambridge Medical Technology | 1983-02-09 | Traditional | PDF ↗ |
| K822892 | CORTISOL RIA KIT | Antibodies, Inc. | 1982-11-01 | Traditional | PDF ↗ |
| K822845 | SOPHEIA CORTISOL EIA KIT | Diagnostic Products Corp. | 1982-10-27 | Traditional | PDF ↗ |
| K821931 | ZETA-CORT | Amf Biological and Diagnostics Co. | 1982-07-22 | Traditional | PDF ↗ |
| K821068 | DSL 1020 | Diagnostic Systems Laboratories, Inc. | 1982-05-05 | Traditional | PDF ↗ |
| K820341 | CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT | E. R. Squibb & Sons, Inc. | 1982-03-04 | Traditional | PDF ↗ |
| K820074 | CORTISOL (RIA) KIT | Immuno Assay Corp. | 1982-01-28 | Traditional | PDF ↗ |
| K810891 | COAT-A-COUNT CORTISOL RIA KIT | Diagnostic Products Corp. | 1981-04-14 | Traditional | PDF ↗ |
| K810192 | ENDAB CORTISOL KIT | Immunotech Corp. | 1981-02-06 | Traditional | PDF ↗ |
| K810033 | CORTI-SHURE | Nuclear Medical Laboratories, Inc. | 1981-01-21 | Traditional | PDF ↗ |
| K802969 | CORTISOL 125-I RADIOIMMUNOASSAY KIT | Ria Products, Inc. | 1981-01-02 | Traditional | PDF ↗ |
| K802380 | ARIA II 125 I CORTISOL | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-10-31 | Traditional | PDF ↗ |
| K802036 | CORTISOL125 RADIOIMMUNOASSAY | Corning Medical & Scientific | 1980-10-23 | Traditional | PDF ↗ |
| K801203 | CORTISOL RADIOIMMUNOASSAY KIT | Technia Diagnostics , Ltd. | 1980-06-09 | Traditional | PDF ↗ |
| K800538 | GAMMA STICK CORTISOL RIA KIT/STICK KIT | Alpha Gamma Laboratory | 1980-04-24 | Traditional | PDF ↗ |
| K800700 | AMERLEX CORTISOL RIA KIT | Amersham Corp. | 1980-04-16 | Traditional | PDF ↗ |
| K800594 | VENTRE/SEP CORTISOL RIA | Ventrex Laboratories, Inc. | 1980-04-04 | Traditional | PDF ↗ |
| K800245 | EMIT AUTO CORTISOL ASSAY | Syva Co. | 1980-03-03 | Traditional | PDF ↗ |
| K800045 | QUANTIMUNE CORTISOL RIA CORTISOL RADIO- | Bio-Rad | 1980-01-23 | Traditional | PDF ↗ |
| K792439 | ANALYTE CORTISOL | Technicon Instruments Corp. | 1980-01-17 | Traditional | PDF ↗ |
| K792243 | CENTRIA CORTISOL RIA TEST SET | Ventrex Laboratories, Inc. | 1979-12-06 | Traditional | PDF ↗ |
| K792036 | CORTISOL RADIOIMMUNOASSAY SYSTEM | Radioimmunoassay, Inc. | 1979-10-30 | Traditional | PDF ↗ |
| K791700 | CORTI-SHURE | Nuclear Medical Laboratories, Inc. | 1979-10-01 | Traditional | PDF ↗ |
| K791835 | CORALENT COAT 125I CORTISOL RADIOIMM. | Radioassay Systems Laboratories, Inc. | 1979-09-27 | Traditional | PDF ↗ |
| K790906 | AUTOPAK CORTISOL TEST DELIVERY SYSTEM | Micromedic Systems | 1979-06-27 | Traditional | PDF ↗ |
| K790268 | CORTISOL RIA KIT | E. R. Squibb & Sons, Inc. | 1979-04-04 | Traditional | PDF ↗ |
| K781903 | RIA KIT, QUANTITOPE CORTISOL | Kallestad Laboratories, Inc. | 1979-01-26 | Traditional | PDF ↗ |
| K782110 | RIA KIT, RIANEN CORTISOL | New England Nuclear | 1979-01-26 | Traditional | PDF ↗ |
| K781730 | RIA, CORTISOL KIT | Radioassay Systems Laboratories, Inc. | 1978-11-22 | Traditional | PDF ↗ |
| K780725 | CENTRIA CORTISOL RIA | Union Carbide Corp. | 1978-06-06 | Traditional | PDF ↗ |
| K771117 | CENTRIA CORTISOL RIA | Clinical Diagnostics, Inc. | 1977-06-23 | Traditional | PDF ↗ |
| K761346 | RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) | New England Nuclear | 1977-01-07 | Traditional | PDF ↗ |
| K760939 | CORTISOL REAGENT SYSTEM | Beckman Instruments, Inc. | 1976-11-16 | Traditional | PDF ↗ |
| K760256 | TEST SYSTEM, RIA CORTISOL | Corning Medical & Scientific | 1976-08-11 | Traditional | PDF ↗ |
Product code CGR · Class II · Clinical Chemistry. Data: openFDA.