Elecsys Cortisol II, Cortisol II CalSet
K-Number: K152227 · 2016-04-27
ApplicantRoche Diagnostics
Decision Date2016-04-27
Product CodeJFT
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Elecsys Cortisol II, Cortisol II CalSet is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2016-04-27 under approval number K152227. 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 II, Cortisol II CalSet?
Elecsys Cortisol II, Cortisol II CalSet is a medical device that received FDA 510(k) clearance on 2016-04-27. It is manufactured by Roche Diagnostics. The 510(k) number is K152227.
When was Elecsys Cortisol II, Cortisol II CalSet approved by the FDA?
Elecsys Cortisol II, Cortisol II CalSet received FDA 510(k) clearance on 2016-04-27, under approval number K152227.
What company makes Elecsys Cortisol II, Cortisol II CalSet?
Elecsys Cortisol II, Cortisol II CalSet is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys Cortisol II, Cortisol II CalSet?
The FDA product code for Elecsys Cortisol II, Cortisol II CalSet 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.