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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K251157
Device Name Core Metabolic
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 Number862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CEK   CFR  
Date Received04/15/2025
Decision Date 01/09/2026
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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