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FDA 510(k)

IntelliSep Test

K-Number: K250912 · 2025-11-19

ApplicantCytovale, Inc.
Decision Date2025-11-19
Product CodeQUT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IntelliSep Test is a medical device manufactured by Cytovale, Inc.. It received FDA 510(k) clearance on 2025-11-19 under approval number K250912. 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?

IntelliSep Test is a medical device that received FDA 510(k) clearance on 2025-11-19. It is manufactured by Cytovale, Inc.. The 510(k) number is K250912.

When was IntelliSep Test approved by the FDA?

IntelliSep Test received FDA 510(k) clearance on 2025-11-19, under approval number K250912.

What company makes IntelliSep Test?

IntelliSep Test is manufactured by Cytovale, Inc..

What is the FDA product code for IntelliSep Test?

The FDA product code for IntelliSep Test is QUT.

Other Devices by Cytovale, Inc.

K220991IntelliSep test K250513IntelliSep Test (CV-ICG-048)

Related Devices (Code: QUT)

K220991IntelliSep testCytovale, Inc. K250513IntelliSep Test (CV-ICG-048)Cytovale, Inc.

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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