FDA 510(k)

ADVIA Centaur 紅血球生成素 (EPO) 測試

K 號：K183088 · 2019-08-02

決定日期2019-08-02

產品代碼GGT

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

ADVIA Centaur Erythropoietin (EPO) assay is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K183088. The device is classified under product code GGT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADVIA Centaur Erythropoietin (EPO) assay?

ADVIA Centaur Erythropoietin (EPO) assay is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Axis-Shield Diagnostics Limited. The 510(k) number is K183088.

When did ADVIA Centaur Erythropoietin (EPO) assay receive FDA 510(k) clearance?

ADVIA Centaur Erythropoietin (EPO) assay received FDA 510(k) clearance on 2019-08-02, under 510(k) number K183088.

Who is the listed applicant for ADVIA Centaur Erythropoietin (EPO) assay?

The FDA 510(k) record lists Axis-Shield Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Erythropoietin (EPO) assay?

The FDA product code for ADVIA Centaur Erythropoietin (EPO) assay is GGT.

其他以 Axis-Shield Diagnostics Limited 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。

K182012ADVIA Centaur 骨髄素 (CALCT) 測試 K153551ADVCentaur Anti-CCP IgG (aCCP)試劑包括反應劑、校準劑、質控品及標準曲線材料。K160757ADVIA Centaur Active-B12 (全反式轉運型維生素B12) (AB12) 測試, ADVIA Centaur Active-B12(AB12) 質量控制，以及 ADVIA Centaur Active-B12 (AB12) 主曲線材料 (MCM)

相關器械（代碼：GGT）

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。

K240182Access EPOBeckman Coulter, Inc.

官方來源

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