IntelliSep Test (CV-ICG-048)
K-Number: K250513 · 2025-03-21
ApplicantCytovale, Inc.
Decision Date2025-03-21
Product CodeQUT
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
IntelliSep Test (CV-ICG-048) is a medical device manufactured by Cytovale, Inc.. It received FDA 510(k) clearance on 2025-03-21 under approval number K250513. The device is classified under product code QUT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IntelliSep Test (CV-ICG-048)?
IntelliSep Test (CV-ICG-048) is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Cytovale, Inc.. The 510(k) number is K250513.
When was IntelliSep Test (CV-ICG-048) approved by the FDA?
IntelliSep Test (CV-ICG-048) received FDA 510(k) clearance on 2025-03-21, under approval number K250513.
What company makes IntelliSep Test (CV-ICG-048)?
IntelliSep Test (CV-ICG-048) is manufactured by Cytovale, Inc..
What is the FDA product code for IntelliSep Test (CV-ICG-048)?
The FDA product code for IntelliSep Test (CV-ICG-048) is QUT.
Other Devices by Cytovale, Inc.
Related Devices (Code: QUT)
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.