FDA 510(k)

Panel de Prueba de Orina de Drogas Multidroga AllTest; Panel de Prueba de Orina Rápida de Drogas Multidroga AllTest

N.º K: K242540 · 2024-09-27

SolicitanteHangzhou AllTest Biotech Co., Ltd.

Fecha de decisión2024-09-27

Código de productoNFT

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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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: NFT)

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Fuente oficial

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