FDA 510(k)

Cassete de Prueba Rápida de Embarazo Alltest

N.º K: K203272 · 2022-01-31

SolicitanteHangzhou AllTest Biotech Co., Ltd.

Fecha de decisión2022-01-31

Código de productoJHI

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Alltest Pregnancy Rapid Combo 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 2022-01-31 under 510(k) number K203272. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Alltest Pregnancy Rapid Combo Test Cassette?

Alltest Pregnancy Rapid Combo Test Cassette is a medical device that received FDA 510(k) clearance on 2022-01-31. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K203272.

When did Alltest Pregnancy Rapid Combo Test Cassette receive FDA 510(k) clearance?

Alltest Pregnancy Rapid Combo Test Cassette received FDA 510(k) clearance on 2022-01-31, under 510(k) number K203272.

Who is the listed applicant for Alltest Pregnancy Rapid Combo 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 Pregnancy Rapid Combo Test Cassette?

The FDA product code for Alltest Pregnancy Rapid Combo Test Cassette is JHI.

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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

Ver todos los 14 dispositivos →

Dispositivos relacionados (Código: JHI)

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.