Axsym Cortisol Assay
FDA 510(k) K033731 · Fujirebio Diagnostics,Inc.
510(k) numberK033731
Submission
- Device name
- Axsym Cortisol Assay
- Applicant
- Fujirebio Diagnostics,Inc.
Malvern, PA, US - Received
- November 28, 2003
- Decision date
- February 20, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFT – Fluorometric, Cortisol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1205
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242505 | Elecsys Cortisol IIIJFT · Traditional | Roche Diagnostics | 07/17/2025SE |
| K192788 | ADVIA Centaur Cortisol (COR)JFT · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/25/2019SE |
| K152227 | Elecsys Cortisol II, Cortisol II CalSetJFT · Traditional | Roche Diagnostics | 04/27/2016SE |
| K142723 | ADVIA Centaur Cortisol (COR) AssyJFT · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/31/2015SE |
| K062204 | Architect Cortisol AssayJFT · Traditional | Seradyn, Inc. | 09/22/2006SE |
| K021218 | Elecsys Cortisol Test SystemJFT · Traditional | Roche Diagnostics Corp. | 09/09/2002SE |
| K962559 | Acs Cortisol ImmunoassayJFT · Traditional | Ciba Corning Diagnostics Corp. | 11/05/1996SE |
| K954591 | Aia-Pack Cort AssayJFT · Traditional | Tosoh Medics, Inc. | 12/15/1995SE |
| K934317 | Cidba Corning Acs Cortisol ImmunoassayJFT · Traditional | Ciba Corning Diagnostics Corp. | 05/13/1994SE |
| K931031 | Vidas Cortisol (Cort) Assay & Serum Free DilutentJFT · Traditional | Biomerieux Vitek, Inc. | 07/27/1993SE |
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Questions and answers
When was Axsym Cortisol Assay cleared by the FDA?
Axsym Cortisol Assay (K033731) received a 510(k) decision of Substantially Equivalent on February 20, 2004, 84 days after the submission was received.
What is the product code of K033731?
The FDA product code is JFT – Fluorometric, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.