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FDA 510(k)

Mission 胆固醇监测系统，Mission 胆固醇专业监测系统

K号: K163406 · 2017-07-11

申请人ACON Laboratories, Inc.
决定日期2017-07-11
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

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K163406. 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 Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System?

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K163406.

When did Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System receive FDA 510(k) clearance?

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System received FDA 510(k) clearance on 2017-07-11, under 510(k) number K163406.

Who is the listed applicant for Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System?

The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System?

The FDA product code for Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明ACON Laboratories, 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。

K261212Flowflex Plus RSV + 流感A/B + COVID快速测试K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripK251749Flowflex Plus RSV + Flu A/B + COVID Home TestK250085On Call® Sure GK 血糖 & 酮体监测系统；On Call® Sure Sync GK 血糖 & 酮体监测系统K250377Flowflex Plus COVID-19 + Flu A/B Home TestK232715Distinct® 数字妊娠测试

查看所有 16 个设备 →

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.K181373延长脂质面板检测Laboratory Corporation of America HoldingsK180504Mission 脂质面板监测系统ACON Laboratories, Inc.

官方来源

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