Lipids— 510(k) K251091

Substantially Equivalent

Truvian Health

FDA 510(k) clearance K251091 for Lipids, Substantially Equivalent on 2025-12-30. Applicant: Truvian Health. Device class: 1.

Clearance details

Applicant: Truvian Health
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2025-04-10
Decision date: 2025-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHH

K232404 — CHOLESTEROL; HDL-cholesterol; LDL-cholesterol; TRIGLYCERIDES2024-08-09
K203597 — Cholesterol22022-06-30
K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides2019-03-27
K181373 — Extended Lipid Panel Assay2018-10-18
K180504 — Mission Lipid Panel Monitoring System2018-03-28

More clearances from Truvian Health

K251157 — Core Metabolic2026-01-09
K251074 — Tru Liver Health Test Panel2025-12-19
K251058 — Tru Kidney Health Test Panel; Tru Analyzer2025-11-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.