下一代测序腫瘤學面板，體細胞或胚系變異檢測系統
PMA 核准號：P190032 · 2026-09-18
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器材摘要
Next generation sequencing oncology panel, somatic or germline variant detection system is the device name listed in this FDA 510(k) record. The listed applicant is Foundation Medicine, Inc.. It received FDA 510(k) clearance on 2026-09-18. The device is classified under product code PQP. It was reviewed by the PA advisory panel.
常見問題
What is the Next generation sequencing oncology panel, somatic or germline variant detection system?
Next generation sequencing oncology panel, somatic or germline variant detection system is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Foundation Medicine, Inc..
When did Next generation sequencing oncology panel, somatic or germline variant detection system receive FDA 510(k) clearance?
The clearance date for Next generation sequencing oncology panel, somatic or germline variant detection system can be found in the official FDA records.
誰是Next generation sequencing oncology panel，體細胞或胚細胞變異檢測系統的登記申請人？
The FDA 510(k) record lists Foundation Medicine, Inc. as the applicant. This does not by itself establish the device manufacturer.
何為新一代测序癌症組面板、體細胞或胚系突變檢測系統的FDA產品代碼？
FDA產品代碼對於下一代测序腫瘤組合檢測，體細胞或胚系變異檢測系統為PQP。
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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