顏色原位雜交，核酸放大，HER2/NEU 基因，乳癌
PMA 核准號：P100024 · 2017-04-12
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器材摘要
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.
常見問題
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.
誰是Chromogenic in situ hybridization、核酸放大、HER2/NEU基因、乳癌的列名申請人？
The FDA 510(k) record lists Dako Denmark A/S as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼為Chromogenic in situ hybridization、核酸放大、HER2/NEU基因、乳癌的產品代碼是什麼？
Chromogenic in situ hybridization，核酸放大，HER2/NEU基因，乳癌的FDA產品代碼為NYQ。
相關臨床試驗
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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