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Access Cortisol Reagents

by Bio-Rad Laboratories, Inc. 510(k)

Active United States

510(k) K926322

Overview

The Access Cortisol Reagents are fluorometric reagents used to measure cortisol concentrations in clinical chemistry assays. They are supplied by Bio‑Rad Laboratories, Inc. and are identified by the product code JFT in the FDA registration database.

The reagents were cleared through a traditional FDA 510(k) submission (K926322) and are classified as a Class II device under regulation 862.1205. They are listed with the FDA as a single product (Access Cortisol Reagents) and are intended for use in laboratory settings for cortisol testing.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK926322 Date26 May 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
Access(R) Cortisol Reagents
510(k) Number
FDA Product Code
JFT
Device Class
Class II
Regulation
21 CFR Part 862.1205
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What are Access Cortisol Reagents used for?

    Access Cortisol Reagents are fluorometric reagents designed to measure cortisol concentrations in clinical chemistry assays. They are intended for use in laboratory settings to perform cortisol testing for diagnostic purposes.

  • How are the Access Cortisol Reagents supplied?

    The reagents are supplied by Bio-Rad Laboratories, Inc. and are identified by the product code JFT in the FDA registration database. They are packaged for laboratory use in clinical chemistry testing.

  • What is the regulatory status of Access Cortisol Reagents?

    The reagents were cleared through a traditional FDA 510(k) submission (K926322) and are classified as a Class II device under regulation 862.1205. They are listed with the FDA as a single product for laboratory cortisol testing.

  • Are there different sizes or models of Access Cortisol Reagents available?

    The device data does not specify different sizes or models of Access Cortisol Reagents. The product is listed as a single item with the product code JFT in the FDA registration database.