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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
510(k) Number K241676
Device Name TriVerity
Applicant
Inflammatix, Inc.
540 Oakmead Pkwy.
Sunnyvale,  CA  94085
Applicant Contact Diana Lane
Correspondent
Inflammatix, Inc.
540 Oakmead Pkwy.
Sunnyvale,  CA  94085
Correspondent Contact Diana Lane
Regulation Number866.3215
Classification Product Code
PRE  
Subsequent Product Code
OOI  
Date Received06/11/2024
Decision Date 01/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT03606382
NCT04094818
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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