FDA 510(k)

CLUNGENE 安非他命测试，CLUNGENE 可卡因测试，CLUNGENE 氧化安眠药测试

K号: K161251 · 2016-08-30

决定日期2016-08-30

产品代码DKZ

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决定实质等同

器械摘要

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests 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 2016-08-30 under 510(k) number K161251. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests?

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests is a medical device that received FDA 510(k) clearance on 2016-08-30. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K161251.

When did CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests receive FDA 510(k) clearance?

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests received FDA 510(k) clearance on 2016-08-30, under 510(k) number K161251.

Who is the listed applicant for CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests?

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 Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests?

The FDA product code for CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests is DKZ.

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：DKZ）

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。

K240670DRI 摇滚药检测Microgenics Corporation K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta药物筛查杯，Xenta药物筛查滴卡Xenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX 药物筛查，94600Quidel Cardiovascular, Inc.K191099Atlas 多药物筛查测试杯，Atlas 多药物筛查测试板Atlas Medical K182719Quidel Triage TOX 药物筛查，94600；Quidel Triage® MeterProQuidel Cardiovascular, Inc.

官方来源

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