Product code JFT— Clinical Chemistry
TDX CORTISOL
- Classification name
- Fluorometric, Cortisol
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code JFT
FDA has cleared devices under product code JFT between 1983 and 2025, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2019
- 2016
- 2015
- 2006
- 2004
- 2002
- 1996
- 1995
- 1994
- 1993
- 1990
- 1989
- 1986
- 1985
Top applicants under product code JFT
Recent clearances under product code JFT
- K242505 — Elecsys Cortisol III
- K192788 — ADVIA Centaur Cortisol (COR)
- K152227 — Elecsys Cortisol II, Cortisol II CalSet
- K142723 — ADVIA Centaur Cortisol (COR) Assy
- K062204 — ARCHITECT CORTISOL ASSAY
- K033731 — AXSYM CORTISOL ASSAY
- K021218 — ELECSYS CORTISOL TEST SYSTEM
- K962559 — ACS CORTISOL IMMUNOASSAY
- K954591 — AIA-PACK CORT ASSAY
- K934317 — CIDBA CORNING ACS CORTISOL IMMUNOASSAY
- K930732 — DELFIA CORTISOL KIT
- K931031 — VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT
- K926322 — ACCESS(R) CORTISOL REAGENTS
- K900010 — NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
- K895421 — CORTISOL TEST SYSTEM
- K893954 — CEDIA CORTISOL ASSAY
- K863422 — DELFIA(TM) CORTISOL KIT
- K854419 — TDX CORTISOL
- K852927 — TDX CORTISOL
- K833932 — SYVA ADVANCE CORTISOL ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.