FDA 510(k)

Elecsys 抗-HBc IgM

K 號：K260049 · 2026-04-07

決定日期2026-04-07

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

Elecsys Anti-HBc IgM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K260049. 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 Elecsys Anti-HBc IgM?

Elecsys Anti-HBc IgM is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Roche Diagnostics. The 510(k) number is K260049.

When did Elecsys Anti-HBc IgM receive FDA 510(k) clearance?

Elecsys Anti-HBc IgM received FDA 510(k) clearance on 2026-04-07, under 510(k) number K260049.

Who is the listed applicant for Elecsys Anti-HBc IgM?

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 Anti-HBc IgM?

The FDA product code for Elecsys Anti-HBc IgM is SEI.

其他以 Roche Diagnostics 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。

K261686Elecsys 磷酸鐵蛋白-Tau (217P) 血漿 K252323cobas pulse 血糖監測系統 K252280Elecsys Anti-SARS-CoV-2 S 醫療設備規範文本 Elecsys Anti-SARS-CoV-2 S 醫療設備，已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的NCT編號為[識別號]，PMID編號為[識別號]。請參考以下URL獲取更多資訊：[URL]。K260046Elecsys 抗-HBc II K260048Elecsys 抗-HAV IgM K260026Tina-quant心臟高敏度CRP III

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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。

K260046Elecsys 抗-HBc IIRoche Diagnostics K254059Access anti-HBc IgMBeckman Coulter, Inc.K253687Access anti-HBc TotalBeckman Coulter, Inc.

官方來源

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