FDA 510(k)

Disposable Pen Injector Assembly

Número K: K240961 · 2024-08-15

RequerenteWuxi Nest Biotechnology Co., Ltd.

Data da decisão2024-08-15

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Pen Injector Assembly is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-15 under 510(k) number K240961. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Pen Injector Assembly?

Disposable Pen Injector Assembly is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. The 510(k) number is K240961.

When did Disposable Pen Injector Assembly receive FDA 510(k) clearance?

Disposable Pen Injector Assembly received FDA 510(k) clearance on 2024-08-15, under 510(k) number K240961.

Who is the listed applicant for Disposable Pen Injector Assembly?

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

What is the FDA product code for Disposable Pen Injector Assembly?

The FDA product code for Disposable Pen Injector Assembly is FMF.

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Outros registros que listam Wuxi Nest Biotechnology Co., Ltd. como candidato(a)

K240774Pen Injector K211256Disposable Sampler Viral Transport Media K210440Disposable Sampler Inactivated Transport Media, Nest ITM

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Fonte oficial

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