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FDA 510(k)

ASI 自动化 RPR（快速血浆反应素）梅毒测试，用于 ASI Evolution 自动梅毒分析仪

K号: K201438 · 2020-10-21

申请人Arlington Scientific, Inc. (Asi)
决定日期2020-10-21
产品代码GMQ
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决定实质等同

器械摘要

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Arlington Scientific, Inc. (Asi). It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K201438. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer?

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Arlington Scientific, Inc. (Asi). The 510(k) number is K201438.

When did ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer receive FDA 510(k) clearance?

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer received FDA 510(k) clearance on 2020-10-21, under 510(k) number K201438.

Who is the listed applicant for ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer?

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

What is the FDA product code for ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer?

The FDA product code for ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer is GMQ.

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Arlington Scientific, Inc. (Asi)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。

K182391ASI 自动化 ASI RPR 测试，用于梅毒的 ASI EvolutionK173376ASI Evolution

相关器械（代码：GMQ）

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。

K250249Gold Standard Diagnostics (GSD) AIX1000 快速血浆反应素（RPR）自动测试系统Gold Standard Diagnostics, LLCK182391ASI 自动化 ASI RPR 测试，用于梅毒的 ASI EvolutionArlington Scientific, Inc. (Asi)K173376ASI EvolutionArlington Scientific, Inc. (Asi)

官方来源

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