LZI 布托啡诺 II 酶联免疫测定
K号: K253082 · 2026-01-16
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决定日期2026-01-16
产品代码DJG
咨询委员会TX
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决定实质等同
器械摘要
LZI Buprenorphine II 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 2026-01-16 under 510(k) number K253082. 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 Buprenorphine II Enzyme Immunoassay?
LZI Buprenorphine II Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K253082.
When did LZI Buprenorphine II Enzyme Immunoassay receive FDA 510(k) clearance?
LZI Buprenorphine II Enzyme Immunoassay received FDA 510(k) clearance on 2026-01-16, under 510(k) number K253082.
Who is the listed applicant for LZI Buprenorphine II 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 Buprenorphine II Enzyme Immunoassay?
The FDA product code for LZI Buprenorphine II 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 LimitedK252520SEFRIA® 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,, LLCK251634LZI 芬太尼 III 酶联免疫测定Lin-Zhi International, Inc.K240124BioSieve™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。
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