FDA 510(k)

Teste Rápido de Strep A AllTest

Número K: K260342 · 2026-04-30

RequerenteHangzhou AllTest Biotech Co., Ltd.

Data da decisão2026-04-30

Código do produtoGTY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

AllTest Strep A Rapid 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 2026-04-30 under 510(k) number K260342. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AllTest Strep A Rapid Test?

AllTest Strep A Rapid Test is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K260342.

When did AllTest Strep A Rapid Test receive FDA 510(k) clearance?

AllTest Strep A Rapid Test received FDA 510(k) clearance on 2026-04-30, under 510(k) number K260342.

Who is the listed applicant for AllTest Strep A Rapid 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 AllTest Strep A Rapid Test?

The FDA product code for AllTest Strep A Rapid Test is GTY.

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

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 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: GTY)

K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripACON Laboratories, Inc.K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC K171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation

Fonte oficial

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