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FDA 510(k)

Acuitas AMR基因检测板

K号: K191288 · 2021-09-30

申请人Opgen, Inc.
决定日期2021-09-30
产品代码PMY
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决定实质等同

器械摘要

Acuitas AMR Gene Panel is the device name listed in this FDA 510(k) record. The listed applicant is Opgen, Inc.. It received FDA 510(k) clearance on 2021-09-30 under 510(k) number K191288. The device is classified under product code PMY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Acuitas AMR Gene Panel?

Acuitas AMR Gene Panel is a medical device that received FDA 510(k) clearance on 2021-09-30. The listed applicant is Opgen, Inc.. The 510(k) number is K191288.

When did Acuitas AMR Gene Panel receive FDA 510(k) clearance?

Acuitas AMR Gene Panel received FDA 510(k) clearance on 2021-09-30, under 510(k) number K191288.

Who is the listed applicant for Acuitas AMR Gene Panel?

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

What is the FDA product code for Acuitas AMR Gene Panel?

The FDA product code for Acuitas AMR Gene Panel is PMY.

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：PMY）

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。

K190275GenePOC CarbaGenepoc, Inc.K152614Xpert Carba-RCepheid

官方来源

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