Product code JFT
- Device name
- Fluorometric, 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 |
|---|---|---|---|
| K242505 | Elecsys Cortisol III | Roche Diagnostics | 2025-07-17 |
| K192788 | ADVIA Centaur Cortisol (COR) | Siemens Healthcare Diagnostics, Inc. | 2019-11-25 |
| K152227 | Elecsys Cortisol II, Cortisol II CalSet | Roche Diagnostics | 2016-04-27 |
| K142723 | ADVIA Centaur Cortisol (COR) Assy | Siemens Healthcare Diagnostics, Inc. | 2015-03-31 |
| K062204 | ARCHITECT CORTISOL ASSAY | Seradyn, Inc. | 2006-09-22 |
| K033731 | AXSYM CORTISOL ASSAY | Fujirebio Diagnostics,Inc. | 2004-02-20 |
| K021218 | ELECSYS CORTISOL TEST SYSTEM | Roche Diagnostics Corp. | 2002-09-09 |
| K962559 | ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-11-05 |
| K954591 | AIA-PACK CORT ASSAY | Tosoh Medics, Inc. | 1995-12-15 |
| K934317 | CIDBA CORNING ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1994-05-13 |
| K930732 | DELFIA CORTISOL KIT | Wallac OY | 1993-07-27 |
| K931031 | VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT | Biomerieux Vitek, Inc. | 1993-07-27 |
| K926322 | ACCESS(R) CORTISOL REAGENTS | Bio-Rad Laboratories, Inc. | 1993-05-26 |
| K900010 | NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-04-03 |
| K895421 | CORTISOL TEST SYSTEM | Baxter Healthcare Corp | 1989-12-07 |
| K893954 | CEDIA CORTISOL ASSAY | Microgenics Corp. | 1989-10-31 |
| K863422 | DELFIA(TM) CORTISOL KIT | Lkb Instruments, Inc. | 1986-09-26 |
| K854419 | TDX CORTISOL | Abbott Laboratories | 1985-11-25 |
| K852927 | TDX CORTISOL | Abbott Laboratories | 1985-08-05 |
| K833932 | SYVA ADVANCE CORTISOL ASSAY | Syva Co. | 1983-12-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336180778 | Elecsys Cortisol III | Roche Diagnostics GmbH | 2025-07-24 |
| 00630414598666 | Atellica IM Cor MCM | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414293608 | Atellica IM Cor | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00630414294155 | Atellica IM Cor | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00380740130060 | Alinity | Abbott Ireland Diagnostics | 2018-08-10 |
| 00380740130053 | Alinity | Abbott Ireland Diagnostics | 2018-08-10 |
| 04015630939985 | Elecsys Cortisol II | Roche Diagnostics GmbH | 2018-06-06 |
| 00630414598673 | Atellica Cort Urine Recon Buffer | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00630414598659 | Atellica IM Cor | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00630414598642 | Atellica IM Cor | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 04560189211704 | AIA-PACK CORT Sample Diluting Solution | TOSOH CORPORATION | 2016-09-24 |
| 00630414602950 | ADVIA Centaur® COR +E | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414602943 | ADVIA Centaur® COR | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414524740 | ADVIA Centaur® COR MCM | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414524610 | ADVIA Centaur® COR +E | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414121819 | ADVIA Centaur Cortisol Urine Reconstitution Buffer | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04560189211698 | AIA-PACK CORT Calibrator Set | TOSOH CORPORATION | 2016-09-24 |
| 14560189210735 | ST AIA-PACK CORT | TOSOH CORPORATION | 2016-09-24 |
| 04015630940677 | Elecsys Cortisol II | Roche Diagnostics GmbH | 2016-09-20 |
| 03573026097295 | VIDAS® Serum Free | BIOMERIEUX SA | 2016-08-31 |
| 03573026551469 | VIDAS® Serum Free | BIOMERIEUX SA | 2016-08-31 |
| 00380740016258 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |
| 00380740016272 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |
| 00380740016265 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |