FDA 510(k)

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test

Número K: K153741 · 2016-03-18

RequerenteHangzhou Clongene Biotech Co., Ltd.

Data da decisão2016-03-18

Código do produtoLDJ

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K153741. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test?

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K153741.

When did CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test receive FDA 510(k) clearance?

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test received FDA 510(k) clearance on 2016-03-18, under 510(k) number K153741.

Who is the listed applicant for CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test?

The FDA 510(k) record lists Hangzhou Clongene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test?

The FDA product code for CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test is LDJ.

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Fonte oficial

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