癌症相关胚系基因突变检测系统
PMA编号：P190014 · 2026-03-10
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决定日期2026-03-10
PMA 编号P190014
产品代码PJG
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
Cancer-related germline gene mutation detection system is the device name listed in this FDA 510(k) record. The listed applicant is Myriad Genetic Laboratories, Inc.. It received FDA 510(k) clearance on 2026-03-10. The device is classified under product code PJG. It was reviewed by the PA advisory panel.
常见问题
What is the Cancer-related germline gene mutation detection system?
Cancer-related germline gene mutation detection system is a medical device that received FDA 510(k) clearance on 2026-03-10. The listed applicant is Myriad Genetic Laboratories, Inc..
When did Cancer-related germline gene mutation detection system receive FDA 510(k) clearance?
The clearance date for Cancer-related germline gene mutation detection system can be found in the official FDA records.
Who is the listed applicant for Cancer-related germline gene mutation detection system?
The FDA 510(k) record lists Myriad Genetic Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cancer-related germline gene mutation detection system?
The FDA product code for Cancer-related germline gene mutation detection system is PJG.
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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