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FDA 510(k)

Webest 多药物尿液杯；Webest 家庭多药物尿液杯

K号: K260355 · 2026-03-09

申请人WEBEST Biotech,, LLC
决定日期2026-03-09
产品代码NFT
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决定实质等同

器械摘要

Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup is the device name listed in this FDA 510(k) record. The listed applicant is WEBEST Biotech,, LLC. It received FDA 510(k) clearance on 2026-03-09 under 510(k) number K260355. 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 Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup?

Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup is a medical device that received FDA 510(k) clearance on 2026-03-09. The listed applicant is WEBEST Biotech,, LLC. The 510(k) number is K260355.

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

Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup received FDA 510(k) clearance on 2026-03-09, under 510(k) number K260355.

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

The FDA 510(k) record lists WEBEST Biotech,, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup?

The FDA product code for Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine 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

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.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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