FDA 510(k)

AccessNT-proBNP

K 號：K232164 · 2024-04-12

決定日期2024-04-12

產品代碼NBC

諮詢委員會CH

決定相當於

器材摘要

Access NT-proBNP 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 2024-04-12 under 510(k) number K232164. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

什麼是Access NT-proBNP？

Access NT-proBNP is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K232164.

Access NT-proBNP於何時獲得FDA 510(k)許可？

Access NT-proBNP received FDA 510(k) clearance on 2024-04-12, under 510(k) number K232164.

誰是Access NT-proBNP的列名申請人？

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。

FDA產品代碼是什麼？Access NT-proBNP？

FDA產品代碼，Access NT-proBNP為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 K252169Access BNP II K254059Access anti-HBc IgM K253687Access anti-HBc Total K251995Access anti-HAV IgM K250588Access德國麻疹IgG

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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.K252169Access BNP IIBeckman Coulter, Inc.K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.K241176Alere NT-proBNP for Alinity i試劑盒Axis-Shield Diagnostics, Ltd.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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