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FDA 510(k)

Extended Lipid Panel Assay

K-Number: K181373 · 2018-10-18

ApplicantLaboratory Corporation of America Holdings
Decision Date2018-10-18
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Extended Lipid Panel Assay is the device name listed in this FDA 510(k) record. The listed applicant is Laboratory Corporation of America Holdings. It received FDA 510(k) clearance on 2018-10-18 under 510(k) number K181373. 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 Extended Lipid Panel Assay?

Extended Lipid Panel Assay is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Laboratory Corporation of America Holdings. The 510(k) number is K181373.

When did Extended Lipid Panel Assay receive FDA 510(k) clearance?

Extended Lipid Panel Assay received FDA 510(k) clearance on 2018-10-18, under 510(k) number K181373.

Who is the listed applicant for Extended Lipid Panel Assay?

The FDA 510(k) record lists Laboratory Corporation of America Holdings as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Extended Lipid Panel Assay?

The FDA product code for Extended Lipid Panel Assay is CHH.

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K180504Mission 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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