FDA 510(k)

Quest Diagnostics HairCheck-DT (Cocaine)

Номер K: K152232 · 2016-11-18

Дата решения2016-11-18

Код продуктаDIO

Консультативный комитетTX

РешениеSubstantially Equivalent

Описание устройства

Quest Diagnostics HairCheck-DT (Cocaine) is the device name listed in this FDA 510(k) record. The listed applicant is Quest Diagnostics Incorporated. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K152232. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Quest Diagnostics HairCheck-DT (Cocaine)?

Quest Diagnostics HairCheck-DT (Cocaine) is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Quest Diagnostics Incorporated. The 510(k) number is K152232.

When did Quest Diagnostics HairCheck-DT (Cocaine) receive FDA 510(k) clearance?

Quest Diagnostics HairCheck-DT (Cocaine) received FDA 510(k) clearance on 2016-11-18, under 510(k) number K152232.

Who is the listed applicant for Quest Diagnostics HairCheck-DT (Cocaine)?

The FDA 510(k) record lists Quest Diagnostics Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quest Diagnostics HairCheck-DT (Cocaine)?

The FDA product code for Quest Diagnostics HairCheck-DT (Cocaine) is DIO.

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: DIO)

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics Corporation K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX K181499DRI Cocaine Metabolite AssayMicrogenics Corporation K170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

Официальный источник

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