下一代测序肿瘤学面板，体细胞或生殖细胞变异检测系统
PMA编号：P160018 · 2018-04-06
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决定日期2018-04-06
PMA 编号P160018
产品代码PQP
设备分类第3类
医疗专科U
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。
器械摘要
Next generation sequencing oncology panel, somatic or germline variant detection system is the device name listed in this FDA 510(k) record. The listed applicant is Foundation Medicine, Inc.. It received FDA 510(k) clearance on 2018-04-06. The device is classified under product code PQP. It was reviewed by the PA advisory panel.
常见问题
What is the Next generation sequencing oncology panel, somatic or germline variant detection system?
Next generation sequencing oncology panel, somatic or germline variant detection system is a medical device that received FDA 510(k) clearance on 2018-04-06. The listed applicant is Foundation Medicine, Inc..
When did Next generation sequencing oncology panel, somatic or germline variant detection system receive FDA 510(k) clearance?
The clearance date for Next generation sequencing oncology panel, somatic or germline variant detection system can be found in the official FDA records.
Next generation sequencing oncology panel，体细胞或生殖细胞变异检测系统的列名申请人是谁？
The FDA 510(k) record lists Foundation Medicine, Inc. as the applicant. This does not by itself establish the device manufacturer.
下一代测序肿瘤检测面板，体细胞或生殖细胞变异检测系统的FDA产品代码是什么？
FDA产品代码为下一代测序肿瘤学面板、体细胞或生殖细胞变异检测系统的产品代码是PQP。
相关临床试验
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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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