FDA 510(k)

Alinity i Toxo IgM

K 號：K233932 · 2024-08-30

決定日期2024-08-30

產品代碼LGD

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 Toxo IgM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K233932. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alinity i Toxo IgM?

Alinity i Toxo IgM is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Abbott Laboratories. The 510(k) number is K233932.

When did Alinity i Toxo IgM receive FDA 510(k) clearance?

Alinity i Toxo IgM received FDA 510(k) clearance on 2024-08-30, under 510(k) number K233932.

Who is the listed applicant for Alinity i Toxo IgM?

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 Toxo IgM?

The FDA product code for Alinity i Toxo IgM is LGD.

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 K243168Alinity i 飛蚊症IgG K243283Alinity h-series 系統 K232669TBI

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相關器械（代碼：LGD）

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。

K242022Access 痘疹病毒IgGBeckman Coulter, Inc.K242095Access 痘疹病毒IgM IIBeckman Coulter, Inc.K210596ARCHITECT Toxo IgGAbbott Laboratories K162678Elecsys Toxo IgM, Elecsys Toxo IgM 精準控制Roche Diagnostics

官方來源

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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。