Cleared Traditional

Tru Liver Health Test Panel

K251074 · Truvian Health · Chemistry
Dec 2025
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K251074 is an FDA 510(k) clearance for the Tru Liver Health Test Panel, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Truvian Health (San Diego, US). The FDA issued a Cleared decision on December 19, 2025, 255 days after receiving the submission on April 8, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K251074 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2025
Decision Date December 19, 2025
Days to Decision 255 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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