FDA 510(k)

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers

Номер K: K201442 · 2020-07-31

Дата решения2020-07-31

Код продуктаLAF

Консультативный комитетTX

РешениеSubstantially Equivalent

Описание устройства

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is the device name listed in this FDA 510(k) record. The listed applicant is Diatron Group. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K201442. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers?

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Diatron Group. The 510(k) number is K201442.

When did Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers receive FDA 510(k) clearance?

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201442.

Who is the listed applicant for Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers?

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

What is the FDA product code for Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers?

The FDA product code for Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is LAF.

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: LAF)

K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation K170222Rapid Tox Cup IIAmerican Bio Medica Corp.K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation

Официальный источник

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