Data / Medical devices / Fluorometric, Cortisol
Fluorometric, Cortisol (JFT): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Fluorometric, Cortisol (product code JFT, Class 2, 21 CFR 862.1205). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on July 17, 2025, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JFT
- Device class
- 2
- Regulation
- 862.1205
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 1 |
| France | 1 |
| Japan | 1 |
| Ireland | 1 |
Makers of Fluorometric, Cortisol
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 3 | November 25, 2019 | 0 | 1 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 2 | July 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Biomerieux SA | MARCY L ETOILE Rhone, France | Manufacturer | 1 | July 27, 1993 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Specification developer | 1 | September 22, 2006 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Manufacturer | 1 | November 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | November 5, 1996 | 0 | 1 | 0 | api.fda.gov |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 1 | December 15, 1995 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.