FDA 510(k)

CLUNGENE 甲基安非他命测试，CLUNGENE 吗啡测试，CLUNGENE 大麻测试

K号: K153741 · 2016-03-18

决定日期2016-03-18

产品代码LDJ

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

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test 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 2016-03-18 under 510(k) number K153741. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test?

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K153741.

When did CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test receive FDA 510(k) clearance?

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test received FDA 510(k) clearance on 2016-03-18, under 510(k) number K153741.

Who is the listed applicant for CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test?

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 Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test?

The FDA product code for CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test is LDJ.

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 K242802CLUNGENE 芬太尼家庭测试条；CLUNGENE 芬太尼测试条 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

查看所有 9 个设备 →

相关器械（代码：LDJ）

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。

K232732Rapid 毒品（THC）测试条 20，Rapid 毒品（THC）测试浸卡 20，Rapid 毒品（THC）测试条 50，Rapid 毒品（THC）测试浸卡 50Co-Innovation Biotech Co., Ltd.K232604LYHER® 尿液大麻（THC）测试套件（条），LYHER® 尿液大麻（THC）测试套件（卡式）Hangzhou Laihe Biotech Co., Ltd.K223162Healgen® 准确度口腔液体药物测试，Healgen® 准确度口腔液体药物测试 COTHealgen Scientific,, LLC K192515BIOEASY大麻测试浸纸卡40，BIOEASY大麻测试浸纸卡20，BIOEASY大麻测试条40，BIOEASY大麻测试条20Shenzhen Bioeasy Biotechnology Co., Ltd.

官方来源

在 FDA 数据库中查看 →

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。