FDA 510(k)

BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel

N.º K: K261280 · 2026-05-22

SolicitanteVivachek Biotech (Hangzhou) Co., Ltd.

Fecha de decisión2026-05-22

Código de productoNFT

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel is the device name listed in this FDA 510(k) record. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K261280. 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 BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel?

BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K261280.

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

BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel received FDA 510(k) clearance on 2026-05-22, under 510(k) number K261280.

Who is the listed applicant for BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel?

The FDA 510(k) record lists Vivachek Biotech (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel?

The FDA product code for BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel is NFT.

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Otros registros que enlistan a Vivachek Biotech (Hangzhou) Co., Ltd. como solicitante

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Dispositivos relacionados (Código: NFT)

K261409BioTeke® Multi-Drug Urine Test CupBioteke Corporation (Wuxi) Co., Ltd.K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLC K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupWEBEST Biotech,, LLC K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc.

Fuente oficial

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