FDA 510(k)

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro

Número K: K250067 · 2025-02-20

RequerenteGuangzhou Decheng Biotechnology Co., Ltd.

Data da decisão2025-02-20

Código do produtoNGL

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K250067. 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 Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro?

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K250067.

When did Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro receive FDA 510(k) clearance?

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro received FDA 510(k) clearance on 2025-02-20, under 510(k) number K250067.

Who is the listed applicant for Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro?

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

What is the FDA product code for Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro?

The FDA product code for Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro is NGL.

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Fonte oficial

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