FDA Product Code
FDA Product Code JFT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1205
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242505 | Elecsys Cortisol III | Roche Diagnostics | 2025-07-17 | Traditional | PDF ↗ |
| K192788 | ADVIA Centaur Cortisol (COR) | Siemens Healthcare Diagnostics, Inc. | 2019-11-25 | Traditional | PDF ↗ |
| K152227 | Elecsys Cortisol II, Cortisol II CalSet | Roche Diagnostics | 2016-04-27 | Traditional | PDF ↗ |
| K142723 | ADVIA Centaur Cortisol (COR) Assy | Siemens Healthcare Diagnostics, Inc. | 2015-03-31 | Traditional | PDF ↗ |
| K062204 | ARCHITECT CORTISOL ASSAY | Seradyn, Inc. | 2006-09-22 | Traditional | PDF ↗ |
| K033731 | AXSYM CORTISOL ASSAY | Fujirebio Diagnostics,Inc. | 2004-02-20 | Traditional | PDF ↗ |
| K021218 | ELECSYS CORTISOL TEST SYSTEM | Roche Diagnostics Corp. | 2002-09-09 | Traditional | PDF ↗ |
| K962559 | ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-11-05 | Traditional | PDF ↗ |
| K954591 | AIA-PACK CORT ASSAY | Tosoh Medics, Inc. | 1995-12-15 | Traditional | PDF ↗ |
| K934317 | CIDBA CORNING ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1994-05-13 | Traditional | PDF ↗ |
| K930732 | DELFIA CORTISOL KIT | Wallac OY | 1993-07-27 | Traditional | PDF ↗ |
| K931031 | VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT | Biomerieux Vitek, Inc. | 1993-07-27 | Traditional | PDF ↗ |
| K926322 | ACCESS(R) CORTISOL REAGENTS | Bio-Rad Laboratories, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K900010 | NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-04-03 | Traditional | PDF ↗ |
| K895421 | CORTISOL TEST SYSTEM | Baxter Healthcare Corp | 1989-12-07 | Traditional | PDF ↗ |
| K893954 | CEDIA CORTISOL ASSAY | Microgenics Corp. | 1989-10-31 | Traditional | PDF ↗ |
| K863422 | DELFIA(TM) CORTISOL KIT | Lkb Instruments, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K854419 | TDX CORTISOL | Abbott Laboratories | 1985-11-25 | Traditional | PDF ↗ |
| K852927 | TDX CORTISOL | Abbott Laboratories | 1985-08-05 | Traditional | PDF ↗ |
| K833932 | SYVA ADVANCE CORTISOL ASSAY | Syva Co. | 1983-12-29 | Traditional | PDF ↗ |
Product code JFT · Class II · Clinical Chemistry. Data: openFDA.