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FDA 510(k)

Atlas 多药物筛查测试杯，Atlas 多药物筛查测试板

K号: K191099 · 2019-10-03

申请人Atlas Medical
决定日期2019-10-03
产品代码DKZ
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

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Medical. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K191099. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel?

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Atlas Medical. The 510(k) number is K191099.

When did Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel receive FDA 510(k) clearance?

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel received FDA 510(k) clearance on 2019-10-03, under 510(k) number K191099.

Who is the listed applicant for Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel?

The FDA 510(k) record lists Atlas Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel?

The FDA product code for Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel is DKZ.

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

相关器械（代码：DKZ）

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。

K240670DRI 摇滚药检测Microgenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta药物筛查杯，Xenta药物筛查滴卡Xenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX 药物筛查，94600Quidel Cardiovascular, Inc.K182719Quidel Triage TOX 药物筛查，94600；Quidel Triage® MeterProQuidel Cardiovascular, Inc.K182738单药和多药快速检测板（尿液），单药和多药快速检测板（尿液），单药和多药快速检测杯（尿液），单药和多药快速检测杯（尿液），单药快速检测试纸条（尿液），单药和多药家庭快速检测板（尿液），单药和多药家庭快速检测杯（尿液），单药家庭快速检测试纸条（尿液）Hangzhou AllTest Biotech Co., Ltd.

官方来源

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