染色原位杂交，核酸扩增，HER2/NEU基因，乳腺癌
PMA编号：P100024 · 2017-04-12
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决定日期2017-04-12
PMA 编号P100024
产品代码NYQ
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
Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is the device name listed in this FDA 510(k) record. The listed applicant is Dako Denmark A/S. It received FDA 510(k) clearance on 2017-04-12. The device is classified under product code NYQ. It was reviewed by the PA advisory panel.
常见问题
What is the Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer?
Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is a medical device that received FDA 510(k) clearance on 2017-04-12. The listed applicant is Dako Denmark A/S.
When did Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer receive FDA 510(k) clearance?
The clearance date for Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer can be found in the official FDA records.
谁是Chromogenic in situ hybridization、核酸扩增、HER2/NEU基因、乳腺癌所列申请人？
The FDA 510(k) record lists Dako Denmark A/S as the applicant. This does not by itself establish the device manufacturer.
FDA产品代码是多少，用于Chromogenic in situ hybridization、核酸扩增、HER2/NEU基因、乳腺癌？
Chromogenic in situ hybridization，核酸扩增，HER2/NEU基因，乳腺癌的FDA产品代码是NYQ。
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官方来源
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