系統，測試，HER-2/NEU，免疫組織化化學染色
PMA 核准號：P090015 · 2026-06-04
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器材摘要
SYSTEM, TEST, HER-2/NEU, IHC is the device name listed in this FDA 510(k) record. The listed applicant is Leica Biosystems. It received FDA 510(k) clearance on 2026-06-04. The device is classified under product code MVC. It was reviewed by the PA advisory panel.
常見問題
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 2026-06-04. The listed applicant is Leica Biosystems.
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.
誰是SYSTEM、TEST、HER-2/NEU、IHC的登記申請人？
The FDA 510(k) record lists Leica Biosystems as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼為SYSTEM、TEST、HER-2/NEU、IHC是什麼？
FDA產品代碼對於SYSTEM、TEST、HER-2/NEU、IHC為MVC。
相關臨床試驗
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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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