FDA 510(k)

Access anti-HBc IgM

K 號：K254059 · 2026-03-13

決定日期2026-03-13

產品代碼SEI

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

Access anti-HBc IgM 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 2026-03-13 under 510(k) number K254059. The device is classified under product code SEI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Access anti-HBc IgM?

Access anti-HBc IgM is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K254059.

When did Access anti-HBc IgM receive FDA 510(k) clearance?

Access anti-HBc IgM received FDA 510(k) clearance on 2026-03-13, under 510(k) number K254059.

Who is the listed applicant for Access anti-HBc IgM?

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 Access anti-HBc IgM?

The FDA product code for Access anti-HBc IgM is SEI.

其他以 Beckman Coulter, Inc. 為申請人之記錄

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。

K262109AccessNT-proBNP K252169Access BNP II K253687Access anti-HBc Total K251995Access anti-HAV IgM K250588Access德國麻疹IgG K252580iQ200 系列

查看所有 73 項裝置 →

相關器械（代碼：SEI）

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。

K260049Elecsys 抗-HBc IgMRoche Diagnostics K260046Elecsys 抗-HBc IIRoche Diagnostics K253687Access anti-HBc TotalBeckman Coulter, Inc.

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。