IntelliSep test— 510(k) K220991

Substantially Equivalent

Cytovale, Inc.

FDA 510(k) clearance K220991 for IntelliSep test, Substantially Equivalent on 2022-12-20. Applicant: Cytovale, Inc..

Clearance details

Applicant: Cytovale, Inc.
Product code: Code QUT
Advisory panel: Microbiology
Date received: 2022-04-04
Decision date: 2022-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

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