FDA 510(k)

自動血液凝固分析儀CN系列（CN-6000）

K 號：K250965 · 2025-06-02

決定日期2025-06-02

產品代碼JPA

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

Automated Blood Coagulation Analyzer CN-Series (CN-6000) 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 2025-06-02 under 510(k) number K250965. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Automated Blood Coagulation Analyzer CN-Series (CN-6000)?

Automated Blood Coagulation Analyzer CN-Series (CN-6000) is a medical device that received FDA 510(k) clearance on 2025-06-02. The listed applicant is Sysmex America, Inc.. The 510(k) number is K250965.

When did Automated Blood Coagulation Analyzer CN-Series (CN-6000) receive FDA 510(k) clearance?

Automated Blood Coagulation Analyzer CN-Series (CN-6000) received FDA 510(k) clearance on 2025-06-02, under 510(k) number K250965.

Who is the listed applicant for Automated Blood Coagulation Analyzer CN-Series (CN-6000)?

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 Automated Blood Coagulation Analyzer CN-Series (CN-6000)?

The FDA product code for Automated Blood Coagulation Analyzer CN-Series (CN-6000) is JPA.

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 K250943Sysmex XR系列（XR-10）自動血液學分析儀 K251371Sysmex XR系列（XR-20）自動血液學分析儀 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：JPA）

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。

K253658STA衛星Max®Diagnostica Stago, Inc.K251024TEG 6s 止血系統經鹽酸處理：K, KH, RT, FF 測試卡匣Haemonetics K243858TEG 6s 止血系統經鹽酸處理：K, KH, RT, FF 測試卡匣Haemonetics Corporation K232018Citrated: K, KH, RTH, FFHHaemonetics Corporation K233790ACL TOP 970 CLInstrumentation Laboratory K221359ACL TOP 970 CL, HemosIL CL 抗心磷脂IgM, HemosIL CL 抗ß2 糖蛋白-I IgMInstrumentation Laboratory CO

官方來源

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