CEDIA 海洛因代谢物（6-AM）检测
K号: K192943 · 2019-12-16
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决定日期2019-12-16
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
CEDIA Heroin Metabolite (6-AM) assay is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2019-12-16 under 510(k) number K192943. 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 CEDIA Heroin Metabolite (6-AM) assay?
CEDIA Heroin Metabolite (6-AM) assay is a medical device that received FDA 510(k) clearance on 2019-12-16. The listed applicant is Microgenics Corporation. The 510(k) number is K192943.
When did CEDIA Heroin Metabolite (6-AM) assay receive FDA 510(k) clearance?
CEDIA Heroin Metabolite (6-AM) assay received FDA 510(k) clearance on 2019-12-16, under 510(k) number K192943.
Who is the listed applicant for CEDIA Heroin Metabolite (6-AM) assay?
The FDA 510(k) record lists Microgenics Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CEDIA Heroin Metabolite (6-AM) assay?
The FDA product code for CEDIA Heroin Metabolite (6-AM) assay is DJG.
相关临床试验
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列明Microgenics Corporation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,, LLCK251634LZI 芬太尼 III 酶联免疫测定Lin-Zhi International, Inc.
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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