Immunohistochemistry Assay, Antibody
PMA 核准號：P250031 · 2026-06-12
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決定日期2026-06-12
PMA 編號P250031
產品代碼SHF
諮詢委員會PA
器材摘要
Immunohistochemistry Assay, Antibody is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). It received FDA 510(k) clearance on 2026-06-12. The device is classified under product code SHF. It was reviewed by the PA advisory panel.
常見問題
What is the Immunohistochemistry Assay, Antibody?
Immunohistochemistry Assay, Antibody is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics).
When did Immunohistochemistry Assay, Antibody receive FDA 510(k) clearance?
The clearance date for Immunohistochemistry Assay, Antibody can be found in the official FDA records.
Who is the listed applicant for Immunohistochemistry Assay, Antibody?
The FDA 510(k) record lists Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Immunohistochemistry Assay, Antibody?
The FDA product code for Immunohistochemistry Assay, Antibody is SHF.
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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