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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 the device name listed in this FDA 510(k) record. The listed applicant is Truvian Health. It received FDA 510(k) clearance on 2025-12-19 under 510(k) 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. The listed applicant is Truvian Health. The 510(k) number is K251074.

When did Tru Liver Health Test Panel receive FDA 510(k) clearance?

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

Who is the listed applicant for Tru Liver Health Test Panel?

The FDA 510(k) record lists Truvian Health as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Truvian Health as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251157Core MetabolicK251091LipidsK251058Tru Kidney Health Test Panel; Tru Analyzer

Related Devices (Code: CJE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK223317Alkaline Phosphatase2Abbott Ireland Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)K162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)Randox Laboratories Limited

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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