FDA 510(k)

Shinetell PlusTM Digital Early Pregnancy Test

Número K: K251053 · 2025-07-15

RequerenteHangzhou AllTest Biotech Co., Ltd.

Data da decisão2025-07-15

Código do produtoLCX

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Shinetell PlusTM Digital Early Pregnancy Test 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 2025-07-15 under 510(k) number K251053. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Shinetell PlusTM Digital Early Pregnancy Test?

Shinetell PlusTM Digital Early Pregnancy Test is a medical device that received FDA 510(k) clearance on 2025-07-15. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K251053.

When did Shinetell PlusTM Digital Early Pregnancy Test receive FDA 510(k) clearance?

Shinetell PlusTM Digital Early Pregnancy Test received FDA 510(k) clearance on 2025-07-15, under 510(k) number K251053.

Who is the listed applicant for Shinetell PlusTM Digital Early Pregnancy Test?

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 Shinetell PlusTM Digital Early Pregnancy Test?

The FDA product code for Shinetell PlusTM Digital Early Pregnancy Test is LCX.

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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 K242576Meio de Transporte Viral AllTest K250727Cup de Teste Rápido de Urina de Multi-Drogas AllTest; Cup de Teste de Urina de Multi-Drogas AllTest K244043AllTest Copo Rápido de Teste de Multi-Drogas; AllTest Copo de Teste de Multi-Drogas K242540Painel de Teste de Urina de Multi-Drogas AllTest; Painel de Teste Rápido de Urina de Multi-Drogas AllTest

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Dispositivos Relacionados (Código: LCX)

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Fonte oficial

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