FDA 510(k)

AllTest Cassete de Teste de Urina de Fentanil

Número K: K233417 · 2023-10-26

RequerenteHangzhou AllTest Biotech Co., Ltd.

Data da decisão2023-10-26

Código do produtoNGL

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

AllTest Fentanyl Urine Test Cassette is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K233417. 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 AllTest Fentanyl Urine Test Cassette?

AllTest Fentanyl Urine Test Cassette is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K233417.

When did AllTest Fentanyl Urine Test Cassette receive FDA 510(k) clearance?

AllTest Fentanyl Urine Test Cassette received FDA 510(k) clearance on 2023-10-26, under 510(k) number K233417.

Who is the listed applicant for AllTest Fentanyl Urine Test Cassette?

The FDA 510(k) record lists Hangzhou AllTest Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllTest Fentanyl Urine Test Cassette?

The FDA product code for AllTest Fentanyl Urine Test Cassette is NGL.

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Outros registros que listam Hangzhou AllTest Biotech Co., Ltd. como candidato(a)

K260342Teste Rápido de Strep A AllTest K252607Teste de Infeção Urinária AllTest K251053Shinetell PlusTM Digital Early Pregnancy Test K250727Cup de Teste Rápido de Urina de Multi-Drogas AllTest; Cup de Teste de Urina de Multi-Drogas AllTest K242576Meio de Transporte Viral AllTest K244043AllTest Copo Rápido de Teste de Multi-Drogas; AllTest Copo de Teste de Multi-Drogas

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Fonte oficial

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