PGDx elio 组织完整
K号: K192063 · 2020-04-24
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决定日期2020-04-24
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
PGDx elio tissue complete is the device name listed in this FDA 510(k) record. The listed applicant is Personal Genome Diagnostics. It received FDA 510(k) clearance on 2020-04-24 under 510(k) number K192063. 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 PGDx elio tissue complete?
PGDx elio tissue complete is a medical device that received FDA 510(k) clearance on 2020-04-24. The listed applicant is Personal Genome Diagnostics. The 510(k) number is K192063.
When did PGDx elio tissue complete receive FDA 510(k) clearance?
PGDx elio tissue complete received FDA 510(k) clearance on 2020-04-24, under 510(k) number K192063.
Who is the listed applicant for PGDx elio tissue complete?
The FDA 510(k) record lists Personal Genome Diagnostics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PGDx elio tissue complete?
The FDA product code for PGDx elio tissue complete 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。
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 GenomicsK202304NYU Langone Genome PACT (可行动癌症靶点的基因组分析)Nyu Langone Medical CenterK190661Omics CoreNanthealth, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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