IntelliSep Test— 510(k) K250912

Substantially Equivalent

Cytovale, Inc.

FDA 510(k) clearance K250912 for IntelliSep Test, Substantially Equivalent on 2025-11-19. Applicant: Cytovale, Inc..

Clearance details

Applicant: Cytovale, Inc.
Product code: Code QUT
Advisory panel: Microbiology
Date received: 2025-03-27
Decision date: 2025-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

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