FDA 510(k)

Access BNP II

K 號：K252169 · 2026-03-24

決定日期2026-03-24

產品代碼NBC

諮詢委員會CH

決定相當於

器材摘要

Access BNP 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 2026-03-24 under 510(k) number K252169. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Access BNP II?

Access BNP II is a medical device that received FDA 510(k) clearance on 2026-03-24. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K252169.

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

Access BNP II received FDA 510(k) clearance on 2026-03-24, under 510(k) number K252169.

Who is the listed applicant for Access BNP 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 BNP II?

The FDA product code for Access BNP II is NBC.

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 K254059Access anti-HBc IgM K253687Access anti-HBc Total K251995Access anti-HAV IgM K250588Access德國麻疹IgG K252580iQ200 系列

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相關器械（代碼：NBC）

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-proBNPBeckman Coulter, Inc.K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.K241176Alere NT-proBNP for Alinity i試劑盒Axis-Shield Diagnostics, Ltd.K232164AccessNT-proBNPBeckman Coulter, Inc.K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.K223637Elecsys proBNP II, Elecsys proBNP II 即時版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。