總合，前列腺特異性抗原（非複合與複合）用於檢測前列腺癌
PMA 核准號：P240021 · 2026-08-26
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決定日期2026-08-26
PMA 編號P240021
產品代碼MTF
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
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer 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 2026-08-26. The device is classified under product code MTF. It was reviewed by the IM advisory panel.
常見問題
What is the Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer?
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer is a medical device that received FDA 510(k) clearance on 2026-08-26. The listed applicant is Siemens Healthcare Diagnostics, Inc..
When did Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer receive FDA 510(k) clearance?
The clearance date for Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer can be found in the official FDA records.
誰是Total前列腺特異抗原（非複合與複合）用於檢測前列腺癌的登記申請人？
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？用於檢測前列腺癌的Total前列腺特異性抗原（非複合與複合）？
FDA產品代碼對於Total，前列腺特異性抗原（非複合與複合）用於檢測前列腺癌的是MTF。
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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