免疫組織化學測試，抗體，閉鎖蛋白18
PMA 核准號：P230018 · 2025-06-20
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決定日期2025-06-20
PMA 編號P230018
產品代碼QZJ
器械分類3 類
醫療專科H
法規編號21 CFR 8
諮詢委員會PA
器材摘要
Immunohistochemistry assay, antibody, claudin 18 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 2025-06-20. The device is classified under product code QZJ. It was reviewed by the PA advisory panel.
常見問題
What is the Immunohistochemistry assay, antibody, claudin 18?
Immunohistochemistry assay, antibody, claudin 18 is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Ventana Medical Systems, Inc..
When did Immunohistochemistry assay, antibody, claudin 18 receive FDA 510(k) clearance?
The clearance date for Immunohistochemistry assay, antibody, claudin 18 can be found in the official FDA records.
Who is the listed applicant for Immunohistochemistry assay, antibody, claudin 18?
The FDA 510(k) record lists Ventana Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Immunohistochemistry assay, antibody, claudin 18?
The FDA product code for Immunohistochemistry assay, antibody, claudin 18 is QZJ.
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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