FDA 510(k)

AssureTech 面板浸入测试；AssureTech 快速杯测试；AssureTech 多药物尿液测试面板；AssureTech 多药物尿液测试杯

K号: K243996 · 2025-02-07

决定日期2025-02-07

产品代码NFT

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决定实质等同

器械摘要

AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech., LLC. It received FDA 510(k) clearance on 2025-02-07 under 510(k) number K243996. 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 AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup?

AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2025-02-07. The listed applicant is Assure Tech., LLC. The 510(k) number is K243996.

When did AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup receive FDA 510(k) clearance?

AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup received FDA 510(k) clearance on 2025-02-07, under 510(k) number K243996.

Who is the listed applicant for AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup?

FDA 510(k)记录显示，Assure Tech., LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup?

The FDA product code for AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup is NFT.

列明Assure Tech., LLC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。

K261984AssureTech 快速杯测试；AssureTech 多药物尿液测试杯 K260754Fastep COVID-19 抗原笔家用检测；Fastep COVID-19 抗原笔检测 K252259AssureTech 快速杯测试；AssureTech 多药物尿液测试杯 K250117FaStep 妊娠快速测试卡式；Fastep HCG 快速测试卡式 K243573FaStep 早期妊娠快速测试条；FaStep 早期妊娠快速测试卡式；FaStep 早期妊娠快速测试中段 K240351FaStep 芬太尼快速测试装置（尿液）；FaStep 快速芬太尼尿液测试（尿液）

查看所有 7 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 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.

官方来源

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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。