FDA 510(k)

IntelliSep Test (CV-ICG-048)

K-Number: K250513 · 2025-03-21

Decision Date2025-03-21

Product CodeQUT

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

IntelliSep Test (CV-ICG-048) is the device name listed in this FDA 510(k) record. The listed applicant is Cytovale, Inc.. It received FDA 510(k) clearance on 2025-03-21 under 510(k) 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. The listed applicant is Cytovale, Inc.. The 510(k) number is K250513.

When did IntelliSep Test (CV-ICG-048) receive FDA 510(k) clearance?

IntelliSep Test (CV-ICG-048) received FDA 510(k) clearance on 2025-03-21, under 510(k) number K250513.

Who is the listed applicant for IntelliSep Test (CV-ICG-048)?

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

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 records listing Cytovale, Inc. as applicant

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.

K250912IntelliSep Test K220991IntelliSep test

Related Devices (Code: QUT)

K250912IntelliSep TestCytovale, Inc.K220991IntelliSep testCytovale, Inc.

Official Source

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