LZI 芬太尼 III 酶联免疫测定
K号: K251634 · 2025-06-18
广告
决定日期2025-06-18
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
LZI Fentanyl III 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 2025-06-18 under 510(k) number K251634. 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 III Enzyme Immunoassay?
LZI Fentanyl III Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K251634.
When did LZI Fentanyl III Enzyme Immunoassay receive FDA 510(k) clearance?
LZI Fentanyl III Enzyme Immunoassay received FDA 510(k) clearance on 2025-06-18, under 510(k) number K251634.
Who is the listed applicant for LZI Fentanyl III 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 III Enzyme Immunoassay?
The FDA product code for LZI Fentanyl III Enzyme Immunoassay is DJG.
相关临床试验
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。
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。
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 LimitedK253082LZI 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 CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)测试套件 - 定性；Healgen® 免疫荧光分析仪 (OG-H180)Healgen Scientific,, LLCK240124BioSieve™芬太尼FIA测试套件；BioSieve™ ToxiSmart FIA阅读器Vivachek Biotech (Hangzhou) 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。
广告