GENESEEQPRIME NGS 肿瘤分析检测（FFPE）（GS6005）
K号: K250003 · 2025-08-29
广告
决定日期2025-08-29
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
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) is the device name listed in this FDA 510(k) record. The listed applicant is Geneseeq Technology, Inc.. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K250003. 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 GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)?
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Geneseeq Technology, Inc.. The 510(k) number is K250003.
When did GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) receive FDA 510(k) clearance?
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) received FDA 510(k) clearance on 2025-08-29, under 510(k) number K250003.
Who is the listed applicant for GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)?
The FDA 510(k) record lists Geneseeq Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)?
The FDA product code for GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) 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。
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。
广告