FDA PMA

P2psa

PMA 核准號：P090026 · 2025-06-16

決定日期2025-06-16

PMA 編號P090026

產品代碼OYA

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

P2psa is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-06-16. The device is classified under product code OYA. It was reviewed by the IM advisory panel.

常見問題

What is the P2psa?

P2psa is a medical device that received FDA 510(k) clearance on 2025-06-16. The listed applicant is Beckman Coulter, Inc..

When did P2psa receive FDA 510(k) clearance?

The clearance date for P2psa can be found in the official FDA records.

Who is the listed applicant for P2psa?

FDA 510(k) 記錄將 Beckman Coulter, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for P2psa?

The FDA product code for P2psa is OYA.

官方來源

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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。