FDA 510(k)

LZI 芬太尼酶联免疫测定

K号: K181159 · 2018-12-03

决定日期2018-12-03

产品代码DJG

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决定实质等同

器械摘要

LZI Fentanyl Enzyme Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2018-12-03 under 510(k) number K181159. 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 LZI Fentanyl Enzyme Immunoassay?

LZI Fentanyl Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2018-12-03. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K181159.

When did LZI Fentanyl Enzyme Immunoassay receive FDA 510(k) clearance?

LZI Fentanyl Enzyme Immunoassay received FDA 510(k) clearance on 2018-12-03, under 510(k) number K181159.

Who is the listed applicant for LZI Fentanyl Enzyme Immunoassay?

The FDA 510(k) record lists Lin-Zhi International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LZI Fentanyl Enzyme Immunoassay?

The FDA product code for LZI Fentanyl Enzyme Immunoassay is DJG.

列明Lin-Zhi International, Inc.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。

K253082LZI 布托啡诺 II 酶联免疫测定 K251634LZI 芬太尼 III 酶联免疫测定 K202007LZI 氧可酮 III 酶联免疫测定 K201938LZI 芬太尼 II 酶联免疫测定 K201223LZI 曲马多酶联免疫测定 K192299LZI 尼古丁 II 酶联免疫测定

查看所有 9 个设备 →

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.

官方来源

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