FDA 510(k)

Alinity i 飛蚊症IgG

K 號：K243168 · 2025-06-20

決定日期2025-06-20

產品代碼LFX

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

Alinity i Rubella IgG is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K243168. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alinity i Rubella IgG?

Alinity i Rubella IgG is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Abbott Laboratories. The 510(k) number is K243168.

When did Alinity i Rubella IgG receive FDA 510(k) clearance?

Alinity i Rubella IgG received FDA 510(k) clearance on 2025-06-20, under 510(k) number K243168.

Who is the listed applicant for Alinity i Rubella IgG?

FDA 510(k) 記錄中將阿培爾實驗室列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Alinity i Rubella IgG?

The FDA product code for Alinity i Rubella IgG is LFX.

其他以 Abbott Laboratories 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。

K262156Anti-HCV Next K252424Anti-HCV Next K243500ARCHITECT庆大霉素 K243283Alinity h-series 系統 K233932Alinity i Toxo IgM K232669TBI

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相關器械（代碼：LFX）

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。

K250588Access德國麻疹IgGBeckman Coulter, Inc.

官方來源

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