FDA 510(k)

Healgen 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

K号: K243365 · 2024-12-17

决定日期2024-12-17

产品代码NGL

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决定实质等同

器械摘要

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K243365. 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 Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup?

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K243365.

When did Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup receive FDA 510(k) clearance?

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup received FDA 510(k) clearance on 2024-12-17, under 510(k) number K243365.

Who is the listed applicant for Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup?

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

What is the FDA product code for Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup?

The FDA product code for Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup is NGL.

列明Healgen Scientific,, 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。

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查看所有 15 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.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.K242802CLUNGENE 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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