Cleared Traditional

Lipids

K251091 · Truvian Health · Chemistry
Dec 2025
Decision
264d
Days
Class 1
Risk

About This 510(k) Submission

K251091 is an FDA 510(k) clearance for the Lipids, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Truvian Health (San Diego, US). The FDA issued a Cleared decision on December 30, 2025, 264 days after receiving the submission on April 10, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K251091 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2025
Decision Date December 30, 2025
Days to Decision 264 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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