FDA 510(k)

快速单/多药物测试杯，快速单/多药物测试滴卡

K号: K153050 · 2016-04-26

决定日期2016-04-26

产品代码DJG

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

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is the device name listed in this FDA 510(k) record. The listed applicant is Co-Innovation Biotech Co., Ltd.. It received FDA 510(k) clearance on 2016-04-26 under 510(k) number K153050. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is a medical device that received FDA 510(k) clearance on 2016-04-26. The listed applicant is Co-Innovation Biotech Co., Ltd.. The 510(k) number is K153050.

When did Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard receive FDA 510(k) clearance?

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard received FDA 510(k) clearance on 2016-04-26, under 510(k) number K153050.

Who is the listed applicant for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

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

What is the FDA product code for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

The FDA product code for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is DJG.

列明Co-Innovation 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。

K241100使用加速非侵入性脑刺激快速治疗PTSD K231904Rapid Fentanyl (FYL) 测试条，Rapid Fentanyl (FYL) 测试浸卡 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 50 K213808Co-Innovation 一步法人绒毛膜促性腺激素 (HCG) 检测试纸，Co-Innovation 一步法人绒毛膜促性腺激素 (HCG) 检测试卡，Co-Innovation 一步法人绒毛膜促性腺激素 (HCG) 检测中段

相关器械（代码：DJG）

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。

K252684Labcorp 芬太尼尿液视觉测试Medtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA尿液多联检测Randox Laboratories Limited K253082LZI 布托啡诺 II 酶联免疫测定Lin-Zhi International, Inc.K252520SEFRIA® 水合吗啡口腔液体Immunalysis Corporation K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)测试套件 - 定性；Healgen® 免疫荧光分析仪 (OG-H180)Healgen Scientific,, LLC K251634LZI 芬太尼 III 酶联免疫测定Lin-Zhi International, Inc.

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