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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K251091
Device Name Lipids
Applicant
Truvian Health
10300 Campus Point Dr.
Suite 190
San Diego,  CA  92121
Applicant Contact Tho Tran
Correspondent
Truvian Health
10300 Campus Point Dr.
Suite 190
San Diego,  CA  92121
Correspondent Contact Tho Tran
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Code
JGY  
Date Received04/10/2025
Decision Date 12/30/2025
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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