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FDA 510(k)

Lipids

K-Number: K251091 · 2025-12-30

ApplicantTruvian Health
Decision Date2025-12-30
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Lipids is the device name listed in this FDA 510(k) record. The listed applicant is Truvian Health. It received FDA 510(k) clearance on 2025-12-30 under 510(k) number K251091. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lipids?

Lipids is a medical device that received FDA 510(k) clearance on 2025-12-30. The listed applicant is Truvian Health. The 510(k) number is K251091.

When did Lipids receive FDA 510(k) clearance?

Lipids received FDA 510(k) clearance on 2025-12-30, under 510(k) number K251091.

Who is the listed applicant for Lipids?

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 Lipids?

The FDA product code for Lipids is CHH.

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 MetabolicK251074Tru Liver Health Test PanelK251058Tru Kidney Health Test Panel; Tru Analyzer

Related Devices (Code: CHH)

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.

K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc.K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, 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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