FDA 510(k)

Extended Lipid Panel Assay

Номер K: K181373 · 2018-10-18

ЗаявительLaboratory Corporation of America Holdings

Дата решения2018-10-18

Код продуктаCHH

Консультативный комитетCH

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: CHH)

K251091LipidsTruvian Health K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.A K203597Cholesterol2Abbott Ireland Diagnostics Division K190490VITROS 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.

Официальный источник

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