測試，前列腺特異性抗原，自由（非複合）以區分前列腺癌與良性狀況
PMA 核准號：P250026 · 2026-05-11
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決定日期2026-05-11
PMA 編號P250026
產品代碼MTG
器械分類3 類
醫療專科U
諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。
器材摘要
Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-05-11. The device is classified under product code MTG. It was reviewed by the IM advisory panel.
常見問題
What is the Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions?
Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Siemens Healthcare Diagnostics, Inc..
When did Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions receive FDA 510(k) clearance?
The clearance date for Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions can be found in the official FDA records.
誰是Test,前列腺特異性抗原，自由（非複合）以區分前列腺癌與良性情況的登記申請人？
FDA 510(k) 記錄將西门子醫療診斷公司列為申請人。這並不單獨確立設備製造商。
FDA產品代碼是什麼？用於區分前列腺癌與良性情況的測試，前列腺特異性抗原，自由型（非複合型）？
FDA產品代碼為Test，前列腺特異性抗原，自由（非複合）用於區分前列腺癌與良性狀況的是MTG。
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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