Cleared Traditional

Core Metabolic

K251157 · Truvian Health · Chemistry
Jan 2026
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K251157 is an FDA 510(k) clearance for the Core Metabolic, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Truvian Health (San Diego, US). The FDA issued a Cleared decision on January 9, 2026, 269 days after receiving the submission on April 15, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K251157 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2025
Decision Date January 09, 2026
Days to Decision 269 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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