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FDA 510(k)

QuickScreen Pro 多药物筛查测试，型号 9395Z

K号: K181945 · 2018-10-18

申请人Phamatech, Inc.
决定日期2018-10-18
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

QuickScreen Pro Multi Drug Screening Test, Model 9395Z is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech, Inc.. It received FDA 510(k) clearance on 2018-10-18 under 510(k) number K181945. 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 QuickScreen Pro Multi Drug Screening Test, Model 9395Z?

QuickScreen Pro Multi Drug Screening Test, Model 9395Z is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Phamatech, Inc.. The 510(k) number is K181945.

When did QuickScreen Pro Multi Drug Screening Test, Model 9395Z receive FDA 510(k) clearance?

QuickScreen Pro Multi Drug Screening Test, Model 9395Z received FDA 510(k) clearance on 2018-10-18, under 510(k) number K181945.

Who is the listed applicant for QuickScreen Pro Multi Drug Screening Test, Model 9395Z?

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

What is the FDA product code for QuickScreen Pro Multi Drug Screening Test, Model 9395Z?

The FDA product code for QuickScreen Pro Multi Drug Screening Test, Model 9395Z 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.K191099Atlas 多药物筛查测试杯，Atlas 多药物筛查测试板Atlas MedicalK182719Quidel Triage TOX 药物筛查，94600；Quidel Triage® MeterProQuidel Cardiovascular, Inc.

官方来源

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