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FDA 510(k)

Elecsys Cortisol III

K-Number: K242505 · 2025-07-17

ApplicantRoche Diagnostics
Decision Date2025-07-17
Product CodeJFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys Cortisol III is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2025-07-17 under 510(k) number K242505. The device is classified under product code JFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys Cortisol III?

Elecsys Cortisol III is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Roche Diagnostics. The 510(k) number is K242505.

When did Elecsys Cortisol III receive FDA 510(k) clearance?

Elecsys Cortisol III received FDA 510(k) clearance on 2025-07-17, under 510(k) number K242505.

Who is the listed applicant for Elecsys Cortisol III?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elecsys Cortisol III?

The FDA product code for Elecsys Cortisol III is JFT.

Other records listing Roche Diagnostics as applicant

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Related Devices (Code: JFT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192788ADVIA Centaur Cortisol (COR)Siemens Healthcare Diagnostics, Inc.K152227Elecsys Cortisol II, Cortisol II CalSetRoche Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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