FDA 510(k)

Extended Lipid Panel Assay

N.º K: K181373 · 2018-10-18

SolicitanteLaboratory Corporation of America Holdings

Fecha de decisión2018-10-18

Código de productoCHH

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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