Tru Liver Health Test Panel— 510(k) K251074

Substantially Equivalent

Truvian Health

FDA 510(k) clearance K251074 for Tru Liver Health Test Panel, Substantially Equivalent on 2025-12-19. Applicant: Truvian Health. Device class: 2.

Clearance details

Applicant: Truvian Health
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2025-04-08
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CJE

K240468 — Alkaline Phosphatase2024-10-16
K223317 — Alkaline Phosphatase22023-07-21
K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin2019-08-30
K171971 — Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer2018-01-25
K171080 — ALP IFCC Gen.22017-05-10

More clearances from Truvian Health

K251157 — Core Metabolic2026-01-09
K251091 — Lipids2025-12-30
K251058 — Tru Kidney Health Test Panel; Tru Analyzer2025-11-26

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