FDA 510(k)

Access anti-HBc Total

K 號：K253687 · 2026-02-19

決定日期2026-02-19

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 Total 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 2026-02-19 under 510(k) number K253687. 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 Total?

Access anti-HBc Total is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K253687.

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

Access anti-HBc Total received FDA 510(k) clearance on 2026-02-19, under 510(k) number K253687.

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

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 Total?

The FDA product code for Access anti-HBc Total 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 K254059Access anti-HBc IgM K251995Access anti-HAV IgM K250588Access德國麻疹IgG K252580iQ200 系列

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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 K254059Access anti-HBc IgMBeckman Coulter, Inc.

官方來源

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