FDA 510(k)

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

Número K: K261280 · 2026-05-22

RequerenteVivachek Biotech (Hangzhou) Co., Ltd.

Data da decisão2026-05-22

Código do produtoNFT

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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

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Dispositivos Relacionados (Código: NFT)

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