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FDA 510(k)

Afinion™ HbA1c, Afinion™ 2 和 Alere Afinion™ AS100 分析儀

K 號：K214117 · 2023-09-27

申請人Abbott Diagnostics Technologies AS
決定日期2023-09-27
產品代碼LCP
諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。
決定相當於

器材摘要

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Technologies AS. It received FDA 510(k) clearance on 2023-09-27 under 510(k) number K214117. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer?

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer is a medical device that received FDA 510(k) clearance on 2023-09-27. The listed applicant is Abbott Diagnostics Technologies AS. The 510(k) number is K214117.

When did Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer receive FDA 510(k) clearance?

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer received FDA 510(k) clearance on 2023-09-27, under 510(k) number K214117.

Who is the listed applicant for Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer?

The FDA 510(k) record lists Abbott Diagnostics Technologies AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer?

The FDA product code for Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer is LCP.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：LCP）

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。

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官方來源

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