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
- 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 | July 17, 2025 |
| K192788 | siemens healthcare diagnostics | ADVIA Centaur Cortisol (COR) | November 25, 2019 |
| K152227 | roche diagnostics | Elecsys Cortisol II, Cortisol II CalSet | April 27, 2016 |
| K142723 | siemens healthcare diagnostics | ADVIA Centaur Cortisol (COR) Assy | March 31, 2015 |
| K062204 | seradyn | ARCHITECT CORTISOL ASSAY | September 22, 2006 |
| K033731 | fujirebio diagnostics | AXSYM CORTISOL ASSAY | February 20, 2004 |
| K021218 | roche diagnostics | ELECSYS CORTISOL TEST SYSTEM | September 9, 2002 |
| K962559 | ciba corning diagnostics | ACS CORTISOL IMMUNOASSAY | November 5, 1996 |
| K954591 | tosoh medics | AIA-PACK CORT ASSAY | December 15, 1995 |
| K934317 | ciba corning diagnostics | CIDBA CORNING ACS CORTISOL IMMUNOASSAY | May 13, 1994 |
| K931031 | biomerieux vitek | VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT | July 27, 1993 |
| K930732 | wallac | DELFIA CORTISOL KIT | July 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 | April 3, 1990 |
| K895421 | baxter healthcare | CORTISOL TEST SYSTEM | December 7, 1989 |
| K893954 | microgenics | CEDIA CORTISOL ASSAY | October 31, 1989 |
| K863422 | lkb instruments | DELFIA(TM) CORTISOL KIT | September 26, 1986 |
| K854419 | abbott laboratories | TDX CORTISOL | November 25, 1985 |
| K852927 | abbott laboratories | TDX CORTISOL | August 5, 1985 |
| K833932 | syva | SYVA ADVANCE CORTISOL ASSAY | December 29, 1983 |