JFT — Fluorometric, Cortisol Class II
FDA product code JFT covers "Fluorometric, Cortisol", a Class II medical device regulated under 21 CFR 862.1205. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JFT
- Device Class
- Class II
- Regulation Number
- 862.1205
- Submission Type
- 510(k)
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242505 | Roche Diagnostics | Elecsys Cortisol III | Jul 17, 2025 |
| K192788 | Siemens Healthcare Diagnostics | ADVIA Centaur Cortisol (COR) | Nov 25, 2019 |
| K152227 | Roche Diagnostics | Elecsys Cortisol II, Cortisol II CalSet | Apr 27, 2016 |
| K142723 | Siemens Healthcare Diagnostics | ADVIA Centaur Cortisol (COR) Assy | Mar 31, 2015 |
| K062204 | Seradyn | ARCHITECT CORTISOL ASSAY | Sep 22, 2006 |
| K033731 | Fujirebio Diagnostics | AXSYM CORTISOL ASSAY | Feb 20, 2004 |
| K021218 | Roche Diagnostics | ELECSYS CORTISOL TEST SYSTEM | Sep 9, 2002 |
| K962559 | Ciba Corning Diagnostics | ACS CORTISOL IMMUNOASSAY | Nov 5, 1996 |
| K954591 | Tosoh Medics | AIA-PACK CORT ASSAY | Dec 15, 1995 |
| K934317 | Ciba Corning Diagnostics | CIDBA CORNING ACS CORTISOL IMMUNOASSAY | May 13, 1994 |
| K930732 | Wallac | DELFIA CORTISOL KIT | Jul 27, 1993 |
| K931031 | Biomerieux Vitek | VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT | Jul 27, 1993 |
| K926322 | Bio-Rad Laboratories | ACCESS(R) CORTISOL REAGENTS | May 26, 1993 |
| K900010 | Kallestad Diag, A Div. Of Erbamont | NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR | Apr 3, 1990 |
| K895421 | Baxter Healthcare | CORTISOL TEST SYSTEM | Dec 7, 1989 |
| K893954 | Microgenics | CEDIA CORTISOL ASSAY | Oct 31, 1989 |
| K863422 | Lkb Instruments | DELFIA(TM) CORTISOL KIT | Sep 26, 1986 |
| K854419 | Abbott Laboratories | TDX CORTISOL | Nov 25, 1985 |
| K852927 | Abbott Laboratories | TDX CORTISOL | Aug 5, 1985 |
| K833932 | Syva | SYVA ADVANCE CORTISOL ASSAY | Dec 29, 1983 |