FDA 510(k)

HAVAb IgG II

K 號：K222850 · 2023-08-10

決定日期2023-08-10

產品代碼LOL

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

HAVAb IgG II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K222850. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HAVAb IgG II?

HAVAb IgG II is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Abbott Laboratories. The 510(k) number is K222850.

When did HAVAb IgG II receive FDA 510(k) clearance?

HAVAb IgG II received FDA 510(k) clearance on 2023-08-10, under 510(k) number K222850.

Who is the listed applicant for HAVAb IgG II?

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 HAVAb IgG II?

The FDA product code for HAVAb IgG II is LOL.

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 K233932Alinity i Toxo IgM

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相關器械（代碼：LOL）

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。

K260048Elecsys 抗-HAV IgMRoche Diagnostics K251995Access anti-HAV IgMBeckman Coulter, Inc.K243846Access anti-HAVBeckman Coulter, Inc.K223403LIAISON 防HAV；LIAISON XSDiaSorin, Inc.K210272LIAISON 防HAVDiaSorin, Inc.K193532LIAISON 抗HAV試劑DiaSorin, Inc.

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。