FDA 510(k)

Alinity h-series 系統

K 號：K220031 · 2023-08-04

決定日期2023-08-04

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

Alinity h-series 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 2023-08-04 under 510(k) number K220031. 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 Alinity h-series System?

Alinity h-series System is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Abbott Laboratories. The 510(k) number is K220031.

When did Alinity h-series System receive FDA 510(k) clearance?

Alinity h-series System received FDA 510(k) clearance on 2023-08-04, under 510(k) number K220031.

Who is the listed applicant for Alinity h-series 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 Alinity h-series System?

The FDA product code for Alinity h-series 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。

K262156Anti-HCV Next K252424Anti-HCV Next K243500ARCHITECT庆大霉素 K243168Alinity i 飛蚊症IgG K243283Alinity h-series 系統 K233932Alinity i Toxo IgM

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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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