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FDA 510(k)

ETERBIO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

K号: K243064 · 2024-11-20

申请人Eterbio, Inc.
决定日期2024-11-20
产品代码NGL
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

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test is the device name listed in this FDA 510(k) record. The listed applicant is Eterbio, Inc.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K243064. 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 ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test?

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Eterbio, Inc.. The 510(k) number is K243064.

When did ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test receive FDA 510(k) clearance?

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test received FDA 510(k) clearance on 2024-11-20, under 510(k) number K243064.

Who is the listed applicant for ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test?

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

What is the FDA product code for ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test?

The FDA product code for ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test is NGL.

相关临床试验

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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：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,, LLCK250803Deepblue 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,, LLCK242802CLUNGENE 芬太尼家庭测试条；CLUNGENE 芬太尼测试条Hangzhou Clongene Biotech Co., Ltd.

官方来源

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