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FDA 510(k)

NYU Langone Genome PACT (可行动癌症靶点的基因组分析)

K号: K202304 · 2021-07-14

申请人Nyu Langone Medical Center
决定日期2021-07-14
产品代码PZM
咨询委员会PA 请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) is the device name listed in this FDA 510(k) record. The listed applicant is Nyu Langone Medical Center. It received FDA 510(k) clearance on 2021-07-14 under 510(k) number K202304. The device is classified under product code PZM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)?

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) is a medical device that received FDA 510(k) clearance on 2021-07-14. The listed applicant is Nyu Langone Medical Center. The 510(k) number is K202304.

When did NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) receive FDA 510(k) clearance?

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) received FDA 510(k) clearance on 2021-07-14, under 510(k) number K202304.

Who is the listed applicant for NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)?

The FDA 510(k) record lists Nyu Langone Medical Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)?

The FDA product code for NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) is PZM.

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：PZM）

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。

K260235CellDx-TissueDatar Cancer Genetics Private LimitedK241868xR 体外诊断设备Tempus AI, Inc.K250003GENESEEQPRIME NGS 肿瘤分析检测（FFPE）（GS6005）Geneseeq Technology, Inc.K210017ACTOnco, ACTOnco IVDAct GenomicsK192063PGDx elio 组织完整Personal Genome DiagnosticsK190661Omics CoreNanthealth, Inc.

官方来源

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