系统，结直肠癌，DNA 甲基化和血红蛋白检测
PMA编号：P230043 · 2026-08-03
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决定日期2026-08-03
PMA 编号P230043
产品代码PHP
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
System, colorectal neoplasia, DNA methylation and hemoglobin detection is the device name listed in this FDA 510(k) record. The listed applicant is Exact Sciences Corporation. It received FDA 510(k) clearance on 2026-08-03. The device is classified under product code PHP. It was reviewed by the PA advisory panel.
常见问题
What is the System, colorectal neoplasia, DNA methylation and hemoglobin detection?
System, colorectal neoplasia, DNA methylation and hemoglobin detection is a medical device that received FDA 510(k) clearance on 2026-08-03. The listed applicant is Exact Sciences Corporation.
When did System, colorectal neoplasia, DNA methylation and hemoglobin detection receive FDA 510(k) clearance?
The clearance date for System, colorectal neoplasia, DNA methylation and hemoglobin detection can be found in the official FDA records.
系统、结直肠癌、DNA甲基化和血红蛋白检测的列名申请人是谁？
The FDA 510(k) record lists Exact Sciences Corporation as the applicant. This does not by itself establish the device manufacturer.
系统、结直肠癌、DNA甲基化和血红蛋白检测的FDA产品代码是什么？
FDA产品代码为System，结直肠癌，DNA甲基化和血红蛋白检测的是PHP。
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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