FDA 510(k)

系統梅克斯 XW-100 自動血液學分析儀

K 號：K210346 · 2022-11-08

決定日期2022-11-08

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

Sysmex XW-100 Automated Hematology Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex America, Inc.. It received FDA 510(k) clearance on 2022-11-08 under 510(k) number K210346. 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 Sysmex XW-100 Automated Hematology Analyzer?

Sysmex XW-100 Automated Hematology Analyzer is a medical device that received FDA 510(k) clearance on 2022-11-08. The listed applicant is Sysmex America, Inc.. The 510(k) number is K210346.

When did Sysmex XW-100 Automated Hematology Analyzer receive FDA 510(k) clearance?

Sysmex XW-100 Automated Hematology Analyzer received FDA 510(k) clearance on 2022-11-08, under 510(k) number K210346.

Who is the listed applicant for Sysmex XW-100 Automated Hematology Analyzer?

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

What is the FDA product code for Sysmex XW-100 Automated Hematology Analyzer?

The FDA product code for Sysmex XW-100 Automated Hematology Analyzer is GKZ.

其他以 Sysmex America, 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。

K253212XR系列（XR-10，XR-20）自動血液學分析儀 K251371Sysmex XR系列（XR-20）自動血液學分析儀 K250943Sysmex XR系列（XR-10）自動血液學分析儀 K250965自動血液凝固分析儀CN系列（CN-6000）K230887Sysmex XQ系列（XQ-320）自動血液學分析儀 K182389Sysmex XN-L自動血液學分析儀

查看所有 12 項裝置 →

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.K250943Sysmex XR系列（XR-10）自動血液學分析儀Sysmex America, Inc.K251371Sysmex XR系列（XR-20）自動血液學分析儀Sysmex America, 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。