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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Deformability Cytometry For Sepsis Risk Assessment
510(k) Number K220991
Device Name IntelliSep test
Applicant
Cytovale, Inc.
150 Executive Park Blvd., Suite 4100
San Francisco,  CA  94134
Applicant Contact Juliet Carrara
Correspondent
Cytovale, Inc.
150 Executive Park Blvd., Suite 4100
San Francisco,  CA  94134
Correspondent Contact Juliet Carrara
Regulation Number866.3215
Classification Product Code
QUT  
Date Received04/04/2022
Decision Date 12/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT04933760
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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