FDA 510(k)

Access EPO

K 號：K240182 · 2024-04-22

決定日期2024-04-22

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

Access EPO 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 2024-04-22 under 510(k) number K240182. 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 Access EPO?

Access EPO is a medical device that received FDA 510(k) clearance on 2024-04-22. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K240182.

When did Access EPO receive FDA 510(k) clearance?

Access EPO received FDA 510(k) clearance on 2024-04-22, under 510(k) number K240182.

Who is the listed applicant for Access EPO?

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 EPO?

The FDA product code for Access EPO is GGT.

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。

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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。

K183088ADVIA Centaur 紅血球生成素 (EPO) 測試Axis-Shield Diagnostics Limited

官方來源

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