FDA 510(k)

CLUNGENE 芬太尼家庭测试条；CLUNGENE 芬太尼测试条

K号: K242802 · 2024-11-08

决定日期2024-11-08

产品代码NGL

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决定实质等同

器械摘要

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) number K242802. 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 CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette?

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette is a medical device that received FDA 510(k) clearance on 2024-11-08. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K242802.

When did CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette receive FDA 510(k) clearance?

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette received FDA 510(k) clearance on 2024-11-08, under 510(k) number K242802.

Who is the listed applicant for CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette?

The FDA 510(k) record lists Hangzhou Clongene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette?

The FDA product code for CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette is NGL.

列明Hangzhou Clongene 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。

K253318Clungene RSV 抗原快速检测 K252118CLUNGENE 多药物测试简易杯；CLUNGENE 多药物家庭测试简易杯 K193132CLUNGENE HCG 孕检快速测试条，CLUNGENE HCG 孕检快速测试条，CLUNGENE HCG 孕检快速测试中段 K190412CLUNGENE 多药物测试滴卡，CLUNGENE 多药物测试简易杯 K181790CLUNGENE 多药物测试滴卡，CLUNGENE 多药物测试简易杯 K180255CLUNGENE 多药物测试滴卡，CLUNGENE 多药物测试简易杯

查看所有 9 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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