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FDA 510(k)

Rheonix STI TriPlex检测，Rheonix EncompassMDx工作站（仪器和软件），Rheonix尿液样本采集套件

K号: K193081 · 2021-12-17

申请人Rheonix, Inc.
决定日期2021-12-17
产品代码QEP
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决定实质等同

器械摘要

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Rheonix, Inc.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K193081. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit?

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Rheonix, Inc.. The 510(k) number is K193081.

When did Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit receive FDA 510(k) clearance?

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit received FDA 510(k) clearance on 2021-12-17, under 510(k) number K193081.

Who is the listed applicant for Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit?

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

What is the FDA product code for Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit?

The FDA product code for Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit is QEP.

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：QEP）

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。

K260917cobas CT/NG 用于 cobas 5800/6800/8800 系统；cobas TV/MG 用于 cobas 5800/6800/8800 系统Roche Molecular Systems, Inc.K253756cobas liat CT/NG 核酸检测Roche Molecular Systems, Inc.K253759科博斯利亚特CT/NG/MG核酸检测Roche Molecular Systems, Inc.K251501维斯比医疗男性性健康检测Visby Medical, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG 核酸检测Roche Molecular Systems, Inc.

官方来源

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