FDA 510(k)

AllTest Cinta de Prueba de Orina de Fentanilo

N.º K: K233417 · 2023-10-26

SolicitanteHangzhou AllTest Biotech Co., Ltd.

Fecha de decisión2023-10-26

Código de productoNGL

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Hangzhou AllTest Biotech Co., Ltd. como solicitante

K260342Prueba Rápida de Strep A AllTest K252607Prueba de Infección de Vía Urinaria AllTest K251053Shinetell PlusTM Digital Early Pregnancy Test K250727Copa de Prueba de Orina Rápida de Drogas Multidroga AllTest; Copa de Prueba de Orina de Drogas Multidroga AllTest K242576Medio de Transporte Viral AllTest K244043Copa de Prueba Rápida de Drogas Multidroga AllTest; Copa de Prueba de Drogas Multidroga AllTest

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Dispositivos relacionados (Código: NGL)

K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardHealgen Scientific,, LLC K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd.K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup PlusGuangzhou Decheng Biotechnology Co., Ltd.K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLC K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc.

Fuente oficial

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