FDA 510(k)

Access 痘疹病毒IgM II

K 號：K242095 · 2024-10-11

決定日期2024-10-11

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

Access Toxo IgM II is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K242095. 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 Access Toxo IgM II?

Access Toxo IgM II is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K242095.

When did Access Toxo IgM II receive FDA 510(k) clearance?

Access Toxo IgM II received FDA 510(k) clearance on 2024-10-11, under 510(k) number K242095.

Who is the listed applicant for Access Toxo IgM II?

FDA 510(k) 記錄將 Beckman Coulter, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Access Toxo IgM II?

The FDA product code for Access Toxo IgM II is LGD.

其他以 Beckman Coulter, Inc. 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。

K262109AccessNT-proBNP K252169Access BNP II K254059Access anti-HBc IgM K253687Access anti-HBc Total K251995Access anti-HAV IgM K250588Access德國麻疹IgG

查看所有 73 項裝置 →

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.K233932Alinity i Toxo IgMAbbott Laboratories K210596ARCHITECT Toxo IgGAbbott Laboratories K162678Elecsys Toxo IgM, Elecsys Toxo IgM 精準控制Roche Diagnostics

官方來源

在 FDA 資料庫中查看 →

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。