FDA 510(k)

BIOEASY Multi-Drug Test Cup

Número K: K193480 · 2020-01-31

RequerenteShenzhen Bioeasy Biotechnology Co., Ltd.

Data da decisão2020-01-31

Código do produtoNGL

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

BIOEASY Multi-Drug Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2020-01-31 under 510(k) number K193480. 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 BIOEASY Multi-Drug Test Cup?

BIOEASY Multi-Drug Test Cup is a medical device that received FDA 510(k) clearance on 2020-01-31. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. The 510(k) number is K193480.

When did BIOEASY Multi-Drug Test Cup receive FDA 510(k) clearance?

BIOEASY Multi-Drug Test Cup received FDA 510(k) clearance on 2020-01-31, under 510(k) number K193480.

Who is the listed applicant for BIOEASY Multi-Drug Test Cup?

The FDA 510(k) record lists Shenzhen Bioeasy Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOEASY Multi-Drug Test Cup?

The FDA product code for BIOEASY Multi-Drug Test Cup is NGL.

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Outros registros que listam Shenzhen Bioeasy Biotechnology Co., Ltd. como candidato(a)

K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip K182530BIOEASY Multi-Drug Test Cup

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Fonte oficial

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