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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K251249
Device Name Tru Hematology Test
Applicant
Truvian Sciences, Inc.
10300 Campus Point Dr.
Suite 190
San Diego,  CA  92121
Applicant Contact Tho Tran
Correspondent
Truvian Sciences, Inc.
10300 Campus Point Dr.
Suite 190
San Diego,  CA  92121
Correspondent Contact Tho Tran
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received04/23/2025
Decision Date 01/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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