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FDA 510(k)

Tru Liver Health Test Panel

K-Number: K251074 · 2025-12-19

ApplicantTruvian Health
Decision Date2025-12-19
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Tru Liver Health Test Panel is a medical device manufactured by Truvian Health. It received FDA 510(k) clearance on 2025-12-19 under approval number K251074. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tru Liver Health Test Panel?

Tru Liver Health Test Panel is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Truvian Health. The 510(k) number is K251074.

When was Tru Liver Health Test Panel approved by the FDA?

Tru Liver Health Test Panel received FDA 510(k) clearance on 2025-12-19, under approval number K251074.

What company makes Tru Liver Health Test Panel?

Tru Liver Health Test Panel is manufactured by Truvian Health.

What is the FDA product code for Tru Liver Health Test Panel?

The FDA product code for Tru Liver Health Test Panel is CJE.

Related Clinical Trials

NCT07593456 NST-SPARK Open-Label Phase 1 STTR (IGNITE) NOT_YET_RECRUITING NCT03256994 CIRSE Registry for SIR-Spheres in France (CIRT-FR) COMPLETED NCT06874296 Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time RECRUITING NCT06305624 Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease RECRUITING NCT06877026 FibroScan-Reproducibility and Repeatability Study COMPLETED

Related PubMed Literature

PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025)

Other Devices by Truvian Health

K251091Lipids K251058Tru Kidney Health Test Panel; Tru Analyzer K251157Core Metabolic

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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