FDA 510(k)

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

Número K: K190412 · 2019-03-21

RequerenteHangzhou Clongene Biotech Co., Ltd.

Data da decisão2019-03-21

Código do produtoNGL

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup 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 2019-03-21 under 510(k) number K190412. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup?

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup is a medical device that received FDA 510(k) clearance on 2019-03-21. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K190412.

When did CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup receive FDA 510(k) clearance?

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup received FDA 510(k) clearance on 2019-03-21, under 510(k) number K190412.

Who is the listed applicant for CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup?

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 Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup?

The FDA product code for CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup is NGL.

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