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 a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2025-07-17 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K242505.
When was Elecsys Cortisol III approved by the FDA?
Elecsys Cortisol III received FDA 510(k) clearance on 2025-07-17, under approval number K242505.
What company makes Elecsys Cortisol III?
Elecsys Cortisol III is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys Cortisol III?
The FDA product code for Elecsys Cortisol III is JFT.
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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.