FDA 510(k)

ADVIA Centaur® NT-proBNPII (PBNPII)

K 號：K220265 · 2023-09-24

決定日期2023-09-24

產品代碼NBC

諮詢委員會CH

決定相當於

器材摘要

ADVIA Centaur® NT-proBNPII (PBNPII) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-09-24 under 510(k) number K220265. 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 ADVIA Centaur® NT-proBNPII (PBNPII)?

ADVIA Centaur® NT-proBNPII (PBNPII) is a medical device that received FDA 510(k) clearance on 2023-09-24. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K220265.

When did ADVIA Centaur® NT-proBNPII (PBNPII) receive FDA 510(k) clearance?

ADVIA Centaur® NT-proBNPII (PBNPII) received FDA 510(k) clearance on 2023-09-24, under 510(k) number K220265.

Who is the listed applicant for ADVIA Centaur® NT-proBNPII (PBNPII)?

FDA 510(k) 記錄將西门子醫療診斷公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ADVIA Centaur® NT-proBNPII (PBNPII)?

The FDA product code for ADVIA Centaur® NT-proBNPII (PBNPII) is NBC.

其他以 Siemens Healthcare Diagnostics, 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。

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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.K232164AccessNT-proBNPBeckman Coulter, 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。