FDA 510(k)

SAFElife T-Cup多药物尿液测试杯；SAFElife T-Cup多药物尿液测试杯 Dx

K号: K252550 · 2025-11-18

决定日期2025-11-18

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

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-11-18 under 510(k) number K252550. 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 SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx?

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K252550.

When did SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx receive FDA 510(k) clearance?

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx received FDA 510(k) clearance on 2025-11-18, under 510(k) number K252550.

Who is the listed applicant for SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx?

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

What is the FDA product code for SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx?

The FDA product code for SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx is NFT.

列明Guangzhou Wondfo Biotech 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。

K260065SAFElife T-Dip多药物尿液测试板；SAFElife T-Dip多药物尿液测试板 Dx K251289WELLlife 新冠抗原检测处方 K241317Wondfo 2019-nCoV 抗原检测（侧流法）K241741SAFElife™芬太尼尿液家庭测试（条）；SAFElife™芬太尼（FTY）尿液测试条；SAFElife™ T-Dip芬太尼尿液家庭测试（滴卡）；SAFElife™ T-Dip芬太尼（FTY）尿液测试板 K202567Wondfo T-Dip 多药物尿液检测板，Wondfo T-Dip 多药物尿液检测板 Rx K182701Wondfo T-Cup 多药物尿液检测杯

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 K261280BioSieve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,, LLC 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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。