K-number	K250912
Device name	IntelliSep Test
Applicant	Cytovale, Inc.
Product code	QUT
Device class	Class II
Decision date	Nov 19, 2025
Decision	Substantially Equivalent
Regulation	866.3215

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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IntelliSep Test

Everything you need for a 510(k) submission. Nothing you don't.