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FDA 510(k)

Tru Kidney Health Test Panel; Tru Analyzer

K-Number: K251058 · 2025-11-26

ApplicantTruvian Health
Decision Date2025-11-26
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Tru Kidney Health Test Panel; Tru Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Truvian Health. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K251058. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tru Kidney Health Test Panel; Tru Analyzer?

Tru Kidney Health Test Panel; Tru Analyzer is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is Truvian Health. The 510(k) number is K251058.

When did Tru Kidney Health Test Panel; Tru Analyzer receive FDA 510(k) clearance?

Tru Kidney Health Test Panel; Tru Analyzer received FDA 510(k) clearance on 2025-11-26, under 510(k) number K251058.

Who is the listed applicant for Tru Kidney Health Test Panel; Tru Analyzer?

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 Kidney Health Test Panel; Tru Analyzer?

The FDA product code for Tru Kidney Health Test Panel; Tru Analyzer is CGX.

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 MetabolicK251091LipidsK251074Tru Liver Health Test Panel

Related Devices (Code: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc.

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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