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FDA 510(k)

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup

Número K: K250803 · 2025-04-15

RequerenteAnhui Deepblue Medical Technological Co., Ltd.
Data da decisão2025-04-15
Código do produtoNGL
Comité consultivoTX
DecisãoSubstantially Equivalent

Resumo do dispositivo

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Deepblue Medical Technological Co., Ltd.. It received FDA 510(k) clearance on 2025-04-15 under 510(k) number K250803. 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 Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup?

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2025-04-15. The listed applicant is Anhui Deepblue Medical Technological Co., Ltd.. The 510(k) number is K250803.

When did Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup receive FDA 510(k) clearance?

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup received FDA 510(k) clearance on 2025-04-15, under 510(k) number K250803.

Who is the listed applicant for Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup?

The FDA 510(k) record lists Anhui Deepblue Medical Technological Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup?

The FDA product code for Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup is NGL.

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