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K Number
K251157

Validate with FDA (Live)

Device Name
Core Metabolic
Manufacturer
Truvian Health
Date Cleared
2026-01-09

(269 days)

Product Code
CIX,CEK,CFR
Regulation Number
862.1035
Type
Traditional
Panel
Clinical Chemistry
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.