延长脂质面板检测
K号: K181373 · 2018-10-18
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决定日期2018-10-18
产品代码CHH
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Extended Lipid Panel Assay is the device name listed in this FDA 510(k) record. The listed applicant is Laboratory Corporation of America Holdings. It received FDA 510(k) clearance on 2018-10-18 under 510(k) number K181373. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Extended Lipid Panel Assay?
Extended Lipid Panel Assay is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Laboratory Corporation of America Holdings. The 510(k) number is K181373.
When did Extended Lipid Panel Assay receive FDA 510(k) clearance?
Extended Lipid Panel Assay received FDA 510(k) clearance on 2018-10-18, under 510(k) number K181373.
Who is the listed applicant for Extended Lipid Panel Assay?
The FDA 510(k) record lists Laboratory Corporation of America Holdings as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Extended Lipid Panel Assay?
The FDA product code for Extended Lipid Panel Assay is CHH.
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。
相关器械（代码：CHH）
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。
K251091LipidsTruvian HealthK232404胆固醇；高密度脂蛋白胆固醇；低密度脂蛋白胆固醇；甘油三酯Medicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT 化学产品 TRIG-CHOL 试纸Ortho-Clinical Diagnostics, Inc.K180504Mission 脂质面板监测系统ACON Laboratories, Inc.K163406Mission 胆固醇监测系统，Mission 胆固醇专业监测系统ACON Laboratories, 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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