FDA 510(k)

Painel de Teste de Urina de Multi-Drogas AllTest; Painel de Teste Rápido de Urina de Multi-Drogas AllTest

Número K: K242540 · 2024-09-27

RequerenteHangzhou AllTest Biotech Co., Ltd.

Data da decisão2024-09-27

Código do produtoNFT

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel 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 2024-09-27 under 510(k) number K242540. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel?

AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K242540.

When did AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel receive FDA 510(k) clearance?

AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel received FDA 510(k) clearance on 2024-09-27, under 510(k) number K242540.

Who is the listed applicant for AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel?

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 Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel?

The FDA product code for AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel is NFT.

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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

Ver todos os 14 dispositivos →

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Fonte oficial

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