FDA 510(k)

BioSieve多药物尿液测试板；BioSieve多药物尿液家庭测试板

K号: K261280 · 2026-05-22

申请人Vivachek Biotech (Hangzhou) Co., Ltd.

决定日期2026-05-22

产品代码NFT

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决定实质等同

器械摘要

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.

常见问题

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.

列明Vivachek Biotech (Hangzhou) Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252554Wisdiag 多药物尿液检测杯；Wisdiag 多药物尿液家庭检测杯 K241869BioSieve™芬太尼FIA家庭测试套件；BioSieve™芬太尼FIA专业测试套件；BioSieve™ Toxismart阅读器 K222126VivaChek™ Fad 血糖监测系统，VivaChek™ Fad 智能血糖监测系统，VivaChek™ Fad 同步血糖监测系统 K240124BioSieve™芬太尼FIA测试套件；BioSieve™ ToxiSmart FIA阅读器 K233058VivaChek Link Plus 血糖监测系统 K233062BioSieve™ 多药物尿液测试板；BioSieve™ 多药物尿液测试板Rx

查看所有 10 个设备 →

相关器械（代码：NFT）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261409BioTeke® 多药物尿液检测杯Bioteke Corporation (Wuxi) Co., Ltd.K261984AssureTech 快速杯测试；AssureTech 多药物尿液测试杯Assure Tech., LLC K260065SAFElife T-Dip多药物尿液测试板；SAFElife T-Dip多药物尿液测试板 DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest 多药物尿液杯；Webest 家庭多药物尿液杯WEBEST Biotech,, LLC K252550SAFElife T-Cup多药物尿液测试杯；SAFElife T-Cup多药物尿液测试杯 DxGuangzhou Wondfo Biotech Co., Ltd.K252867VINScreen 尿液药物检测杯；VINScreen 尿液药物家用检测杯Advin Biotech, Inc.

官方来源

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