510(k) K251058

Tru Kidney Health Test Panel; Tru Analyzer by Truvian Health — Product Code CGX

K251058 is an FDA 510(k) premarket notification submitted by Truvian Health for the device "Tru Kidney Health Test Panel; Tru Analyzer". The FDA issued a decision of Substantially Equivalent on November 26, 2025. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Truvian Health has at least 3 other 510(k) clearances on record.