FDA 510(k)

SAFElife T-Dip多药物尿液测试板；SAFElife T-Dip多药物尿液测试板 Dx

K号: K260065 · 2026-04-28

决定日期2026-04-28

产品代码NFT

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决定实质等同

器械摘要

SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel 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 2026-04-28 under 510(k) number K260065. 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-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx?

SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx is a medical device that received FDA 510(k) clearance on 2026-04-28. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K260065.

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

SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx received FDA 510(k) clearance on 2026-04-28, under 510(k) number K260065.

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

The FDA product code for SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel 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。

K252550SAFElife T-Cup多药物尿液测试杯；SAFElife T-Cup多药物尿液测试杯 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.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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