FDA 510(k)

CELL-DYN 綠寶石 22 AL 系統

K 號：K190294 · 2019-03-15

決定日期2019-03-15

產品代碼GKZ

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

CELL-DYN Emerald 22 AL System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K190294. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CELL-DYN Emerald 22 AL System?

CELL-DYN Emerald 22 AL System is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Abbott Laboratories. The 510(k) number is K190294.

When did CELL-DYN Emerald 22 AL System receive FDA 510(k) clearance?

CELL-DYN Emerald 22 AL System received FDA 510(k) clearance on 2019-03-15, under 510(k) number K190294.

Who is the listed applicant for CELL-DYN Emerald 22 AL System?

FDA 510(k) 記錄中將阿培爾實驗室列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CELL-DYN Emerald 22 AL System?

The FDA product code for CELL-DYN Emerald 22 AL System is GKZ.

其他以 Abbott Laboratories 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：GKZ）

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。

K260781裕米森 H550HORIBA ABX SAS K253212XR系列（XR-10，XR-20）自動血液學分析儀Sysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249真血學檢測Truvian Sciences, Inc.K251371Sysmex XR系列（XR-20）自動血液學分析儀Sysmex America, Inc.K250943Sysmex XR系列（XR-10）自動血液學分析儀Sysmex America, Inc.

官方來源

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