FDA 510(k)

ST AIA-PACK BNP 注意：此翻譯僅根據給定的政策進行，並保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址。

K 號：K192380 · 2020-08-24

決定日期2020-08-24

產品代碼NBC

諮詢委員會CH

決定相當於

器材摘要

ST AIA-PACK BNP is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2020-08-24 under 510(k) number K192380. 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 ST AIA-PACK BNP?

ST AIA-PACK BNP is a medical device that received FDA 510(k) clearance on 2020-08-24. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K192380.

When did ST AIA-PACK BNP receive FDA 510(k) clearance?

ST AIA-PACK BNP received FDA 510(k) clearance on 2020-08-24, under 510(k) number K192380.

Who is the listed applicant for ST AIA-PACK BNP?

The FDA 510(k) record lists Fujirebio Diagnostics,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ST AIA-PACK BNP?

The FDA product code for ST AIA-PACK BNP is NBC.

其他以 Fujirebio 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。

K250925ADVIA Centaur 維甲酸片段 21-1 K242706Lumipulse G pTau217/β-Amyloid 1-42 血漿比值 K192524Lumipulse G CA15-3 K200997Lumipulse G CA19-9-N K190702Lumipulse G 全部 PTH K172713Lumipulse G B•R•A•H•M•S PCT 免疫反應芯片，Lumipulse G B•R•A•H•M•S PCT 定標器組

查看所有 17 項裝置 →

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.K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.

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。