FDA 510(k)

Sysmex XR系列（XR-10）自動血液學分析儀

K 號：K250943 · 2025-06-25

決定日期2025-06-25

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 XR-Series (XR-10) 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 2025-06-25 under 510(k) number K250943. 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 XR-Series (XR-10) Automated Hematology Analyzer?

Sysmex XR-Series (XR-10) Automated Hematology Analyzer is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Sysmex America, Inc.. The 510(k) number is K250943.

When did Sysmex XR-Series (XR-10) Automated Hematology Analyzer receive FDA 510(k) clearance?

Sysmex XR-Series (XR-10) Automated Hematology Analyzer received FDA 510(k) clearance on 2025-06-25, under 510(k) number K250943.

Who is the listed applicant for Sysmex XR-Series (XR-10) 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 XR-Series (XR-10) Automated Hematology Analyzer?

The FDA product code for Sysmex XR-Series (XR-10) Automated Hematology Analyzer is GKZ.

其他以 Sysmex America, Inc. 為申請人之記錄

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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 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 K210346系統梅克斯 XW-100 自動血液學分析儀 K182389Sysmex XN-L自動血液學分析儀

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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.K243283Alinity h-series 系統Abbott Laboratories

官方來源

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