FDA 510(k)

TEG 6s 止血系統

K 號：K160502 · 2017-04-19

決定日期2017-04-19

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 is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corporation. It received FDA 510(k) clearance on 2017-04-19 under 510(k) number K160502. 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?

TEG 6s Hemostasis System is a medical device that received FDA 510(k) clearance on 2017-04-19. The listed applicant is Haemonetics Corporation. The 510(k) number is K160502.

When did TEG 6s Hemostasis System receive FDA 510(k) clearance?

TEG 6s Hemostasis System received FDA 510(k) clearance on 2017-04-19, under 510(k) number K160502.

Who is the listed applicant for TEG 6s Hemostasis System?

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

What is the FDA product code for TEG 6s Hemostasis System?

The FDA product code for TEG 6s Hemostasis System is JPA.

其他以 Haemonetics Corporation 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。

K243858TEG 6s 止血系統經鹽酸處理：K, KH, RT, FF 測試卡匣 K232018Citrated: K, KH, RTH, FFH K221722海美尼克細胞儲存精英/精英+ 自體輸血系統 (CSE-E-US/CSE-EW-US)K183160TEG 6s 止血系統，TEG 6s 經鹽酸處理：K, RT, FF 測試卡匣 K162423海美尼克斯細胞儲存精英/精英+ 自體輸血系統 K160197海美尼克斯細胞儲存精英自動輸血系統

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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.K250965自動血液凝固分析儀CN系列（CN-6000）Sysmex America, 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

官方來源

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