Documento fuente o registro público
FDA 510(k) K251074 — Tru Liver Health Test Panel
FDA 510(k) index record K251074. Device: Tru Liver Health Test Panel. Applicant as listed: Truvian Health. Decision date: 2025-12-19.
Fuente
"device_name": "Tru Liver Health Test Panel"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-23
professional use
FDA 510(k) public index record K251074.
Device name: Tru Liver Health Test Panel. Applicant as listed: Truvian Health.
Decision date: 2025-12-19. Decision wording: Substantially Equivalent.
Product code: CJE. Regulation: 21 CFR 862.1050. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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