510(k) K251157

Core Metabolic by Truvian Health — Product Code CIX

K251157 is an FDA 510(k) premarket notification submitted by Truvian Health for the device "Core Metabolic". The FDA issued a decision of Substantially Equivalent on January 9, 2026. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Truvian Health has at least 3 other 510(k) clearances on record.