Tru Kidney Health Test Panel; Tru Analyzer— 510(k) K251058

Name: FDA 510(k) clearance K251058
Creator: U.S. Food and Drug Administration
Published: 2025-11-26

Substantially Equivalent

Truvian Health

FDA 510(k) clearance K251058 for Tru Kidney Health Test Panel; Tru Analyzer, Substantially Equivalent on 2025-11-26. Applicant: Truvian Health. Device class: 2.

Clearance details

Applicant: Truvian Health
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2025-04-04
Decision date: 2025-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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