FDA 510(k)

Elecsys 磷酸鐵蛋白-Tau (181P) 血漿

K 號：K252163 · 2025-10-08

決定日期2025-10-08

產品代碼SET

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]。

決定相當於

器材摘要

Elecsys Phospho-Tau (181P) Plasma is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2025-10-08 under 510(k) number K252163. The device is classified under product code SET. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elecsys Phospho-Tau (181P) Plasma?

Elecsys Phospho-Tau (181P) Plasma is a medical device that received FDA 510(k) clearance on 2025-10-08. The listed applicant is Roche Diagnostics. The 510(k) number is K252163.

When did Elecsys Phospho-Tau (181P) Plasma receive FDA 510(k) clearance?

Elecsys Phospho-Tau (181P) Plasma received FDA 510(k) clearance on 2025-10-08, under 510(k) number K252163.

Who is the listed applicant for Elecsys Phospho-Tau (181P) Plasma?

FDA 510(k) 記錄將羅氏醫學診斷列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Elecsys Phospho-Tau (181P) Plasma?

The FDA product code for Elecsys Phospho-Tau (181P) Plasma is SET.