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FDA 510(k)

Unicel DxH 800 細胞分析系統搭配早期敗血症指示應用程序

K 號：K181599 · 2019-03-18

申請人Beckman Coulter
決定日期2019-03-18
產品代碼QFS
諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)
決定相當於

器材摘要

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter. It received FDA 510(k) clearance on 2019-03-18 under 510(k) number K181599. The device is classified under product code QFS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application?

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application is a medical device that received FDA 510(k) clearance on 2019-03-18. The listed applicant is Beckman Coulter. The 510(k) number is K181599.

When did Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application receive FDA 510(k) clearance?

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application received FDA 510(k) clearance on 2019-03-18, under 510(k) number K181599.

Who is the listed applicant for Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application?

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

What is the FDA product code for Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application?

The FDA product code for Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application is QFS.

相關臨床試驗

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其他以 Beckman Coulter 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。

K232904Access鹼性磷酸酶K193124Unicel DxH 800 考特細胞分析系統K182886Cytomics FC 500 系列流式細胞儀（MPL 或 MCL）K183592ClearLLab 10C面板（B、T、M1、M2），Navios流式細胞儀，Navios EX流式細胞儀K181475DxH 520 體液儀器K162897Navios EX 流式細胞儀，6 色光/2 激光，Navios EX 流式細胞儀，8 色光/2 激光，Navios EX 流式細胞儀，10 色光/3 激光

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