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FDA 510(k)

iSWAB-呼吸道样本采集介质-提取减少（iSWAB-RC-EL）

K号: K221802 · 2023-04-03

申请人Mawi Dna Technologies
决定日期2023-04-03
产品代码QBD
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决定实质等同

器械摘要

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is the device name listed in this FDA 510(k) record. The listed applicant is Mawi Dna Technologies. It received FDA 510(k) clearance on 2023-04-03 under 510(k) number K221802. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)?

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is a medical device that received FDA 510(k) clearance on 2023-04-03. The listed applicant is Mawi Dna Technologies. The 510(k) number is K221802.

When did iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) receive FDA 510(k) clearance?

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) received FDA 510(k) clearance on 2023-04-03, under 510(k) number K221802.

Who is the listed applicant for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)?

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

What is the FDA product code for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)?

The FDA product code for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is QBD.

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：QBD）

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。

K242820Puritan PurSafe Plus 收集和运输系统Puritan Medical Products, LLCK240797PPH 唾液收集套件Permantis Public HealthK222771样本保存液Hangzhou Bioer Technology Co., Ltd.K233324分子运输介质 - MTMAlb LuzK221547InActiv 蓝色Fertipro NVK212878样本保存溶液Zhejiang Gene Science Co., Ltd.

官方来源

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