FDA 510(k)

FaStep 芬太尼快速测试装置（尿液）；FaStep 快速芬太尼尿液测试（尿液）

K号: K240351 · 2024-03-06

决定日期2024-03-06

产品代码NGL

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决定实质等同

器械摘要

FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) 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 2024-03-06 under 510(k) number K240351. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)?

FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Assure Tech., LLC. The 510(k) number is K240351.

When did FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) receive FDA 510(k) clearance?

FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) received FDA 510(k) clearance on 2024-03-06, under 510(k) number K240351.

Who is the listed applicant for FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)?

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 FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)?

The FDA product code for FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) is NGL.

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 K243996AssureTech 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 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

查看所有 7 个设备 →

相关器械（代码：NGL）

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。

K253567Healgen 准确尿液药物筛查条；Healgen 准确家庭尿液药物测试条Healgen Scientific,, LLC K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.K250067Dochek®多药物尿液测试杯；Dochek®多药物尿液测试杯ProGuangzhou Decheng Biotechnology Co., Ltd.K242428Dochek®芬太尼尿液测试条，Dochek®芬太尼尿液测试条加强版，Dochek®芬太尼尿液测试卡，Dochek®芬太尼尿液测试卡加强版，Dochek®芬太尼尿液测试杯和Dochek®芬太尼尿液测试杯加强版Guangzhou Decheng Biotechnology Co., Ltd.K243365Healgen 准确多药物尿液药物筛查杯；Healgen 准确家庭多药物尿液测试杯Healgen Scientific,, LLC K243064ETERBIO芬太尼/诺芬太尼快速测试（胶体金）；ETERBIO芬太尼/诺芬太尼家用测试Eterbio, Inc.

官方来源

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