FDA 510(k)

Cassete de Teste Rápido de Gravidez Alltest

Número K: K203272 · 2022-01-31

RequerenteHangzhou AllTest Biotech Co., Ltd.

Data da decisão2022-01-31

Código do produtoJHI

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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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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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.

Fonte oficial

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