系統，大腸直腸瘜肉，DNA甲基化和血紅素檢測
PMA 核准號：P230009 · 2026-09-16
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決定日期2026-09-16
PMA 編號P230009
產品代碼PHP
器械分類3 類
醫療專科U
諮詢委員會MG
(請提供完整的英文描述，以便進行翻譯。)
器材摘要
System, colorectal neoplasia, DNA methylation and hemoglobin detection is the device name listed in this FDA 510(k) record. The listed applicant is Guardant Health, Inc.. It received FDA 510(k) clearance on 2026-09-16. The device is classified under product code PHP. It was reviewed by the MG advisory panel.
常見問題
What is the System, colorectal neoplasia, DNA methylation and hemoglobin detection?
System, colorectal neoplasia, DNA methylation and hemoglobin detection is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Guardant Health, Inc..
When did System, colorectal neoplasia, DNA methylation and hemoglobin detection receive FDA 510(k) clearance?
The clearance date for System, colorectal neoplasia, DNA methylation and hemoglobin detection can be found in the official FDA records.
誰是System、大腸直腸瘜肉、DNA甲基化和血紅素檢測的登記申請人？
The FDA 510(k) record lists Guardant Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼為系統、大腸腫瘤、DNA甲基化和血紅素檢測的何者？
FDA產品代碼為System、大腸直腸瘜肉、DNA甲基化和血紅素檢測的產品代碼為PHP。
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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