FDA 510(k)

TEG 6s 止血系統經鹽酸處理：K, KH, RT, FF 測試卡匣

K 號：K251024 · 2025-04-30

決定日期2025-04-30

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

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics. It received FDA 510(k) clearance on 2025-04-30 under 510(k) number K251024. 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 TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge?

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge is a medical device that received FDA 510(k) clearance on 2025-04-30. The listed applicant is Haemonetics. The 510(k) number is K251024.

When did TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge receive FDA 510(k) clearance?

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge received FDA 510(k) clearance on 2025-04-30, under 510(k) number K251024.

Who is the listed applicant for TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge?

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

What is the FDA product code for TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge?

The FDA product code for TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge is JPA.

相關器械（代碼：JPA）

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K253658STA衛星Max®Diagnostica Stago, Inc.K250965自動血液凝固分析儀CN系列（CN-6000）Sysmex America, Inc.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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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：JPA）

官方來源