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：P910065 · 2019-06-18
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決定日期2019-06-18
PMA 編號P910065
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 Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2019-06-18. 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 2019-06-18. The listed applicant is Tosoh Bioscience, 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？
The FDA 510(k) record lists Tosoh Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.
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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