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FDA 510(k)

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

N.º K: K201442 · 2020-07-31

SolicitanteDiatron Group
Fecha de decisión2020-07-31
Código de productoLAF
Comité asesorTX
DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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