FDA PMA

多分析測試系統，具有演算法分析功能，用於檢測前列腺癌

PMA 核准號：P190022 · 2025-07-25

決定日期2025-07-25

PMA 編號P190022

產品代碼QRF

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

Multi-analyte test system with algorithmic analysis for detection of prostate cancer is the device name listed in this FDA 510(k) record. The listed applicant is Opko Health, Inc.. It received FDA 510(k) clearance on 2025-07-25. The device is classified under product code QRF. It was reviewed by the IM advisory panel.

常見問題

What is the Multi-analyte test system with algorithmic analysis for detection of prostate cancer?

Multi-analyte test system with algorithmic analysis for detection of prostate cancer is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is Opko Health, Inc..

When did Multi-analyte test system with algorithmic analysis for detection of prostate cancer receive FDA 510(k) clearance?

The clearance date for Multi-analyte test system with algorithmic analysis for detection of prostate cancer can be found in the official FDA records.

誰是列出的多分析測試系統（具有算法分析以檢測前列腺癌）的申請人？

The FDA 510(k) record lists Opko Health, 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多分析測試系統具有算法分析功能？

FDA產品代碼為使用演算法分析檢測前列腺癌的多分析測試系統為QRF。

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。