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/ Cytovale, Inc.
Cytovale, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K250912
IntelliSep Test
November 19, 2025
K250513
IntelliSep Test (CV-ICG-048)
March 21, 2025
K220991
IntelliSep test
December 20, 2022