SYSTEM，测试，HER-2/NEU，免疫组化
PMA编号：P990081 · 2026-08-25
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决定日期2026-08-25
PMA 编号P990081
产品代码MVC
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, TEST, HER-2/NEU, IHC is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-08-25. The device is classified under product code MVC. It was reviewed by the PA advisory panel.
常见问题
What is the SYSTEM, TEST, HER-2/NEU, IHC?
SYSTEM, TEST, HER-2/NEU, IHC is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Ventana Medical Systems, Inc..
When did SYSTEM, TEST, HER-2/NEU, IHC receive FDA 510(k) clearance?
The clearance date for SYSTEM, TEST, HER-2/NEU, IHC can be found in the official FDA records.
SYSTEM、TEST、HER-2/NEU、IHC的列名申请人是谁？
The FDA 510(k) record lists Ventana Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
什么是SYSTEM、TEST、HER-2/NEU、IHC的FDA产品代码？
FDA产品代码为SYSTEM、TEST、HER-2/NEU、IHC的SYSTEM是MVC。
相关临床试验
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官方来源
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