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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K251058
Device Name Tru Kidney Health Test Panel; Tru Analyzer
Applicant
Truvian Health
10300 Campus Pt. Dr.
Suite 190
San Diego,  CA  92121
Applicant Contact Tho Tran
Correspondent
Truvian Health
10300 Campus Pt. Dr.
Suite 190
San Diego,  CA  92121
Correspondent Contact Tho Tran
Regulation Number862.1225
Classification Product Code
CGX  
Subsequent Product Codes
CDN   JJG  
Date Received04/04/2025
Decision Date 11/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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