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FDA 510(k)

Wisdiag 多药物尿液检测杯；Wisdiag 多药物尿液家庭检测杯

K号: K252554 · 2025-09-12

申请人Vivachek Biotech (Hangzhou) Co., Ltd.
决定日期2025-09-12
产品代码NFT
咨询委员会TX 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup 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 2025-09-12 under 510(k) number K252554. 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 Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup?

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K252554.

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

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup received FDA 510(k) clearance on 2025-09-12, under 510(k) number K252554.

Who is the listed applicant for Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup?

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 Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup?

The FDA product code for Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup is NFT.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K261280BioSieve多药物尿液测试板；BioSieve多药物尿液家庭测试板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., LLCK261280BioSieve多药物尿液测试板；BioSieve多药物尿液家庭测试板Vivachek Biotech (Hangzhou) Co., Ltd.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,, LLCK252550SAFElife 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.

官方来源

在 FDA 数据库中查看 →

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