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FDA 510(k)

迪亞茲美凝血因子測試，迪亞茲美凝血因子校准組，迪亞茲美凝血因子控制組

K 號：K143470 · 2016-01-31

申請人Diazyme Laboratories
決定日期2016-01-31
產品代碼GIS
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

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2016-01-31 under 510(k) number K143470. The device is classified under product code GIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set?

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set is a medical device that received FDA 510(k) clearance on 2016-01-31. The listed applicant is Diazyme Laboratories. The 510(k) number is K143470.

When did Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set receive FDA 510(k) clearance?

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set received FDA 510(k) clearance on 2016-01-31, under 510(k) number K143470.

Who is the listed applicant for Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set?

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

What is the FDA product code for Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set?

The FDA product code for Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set is GIS.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Diazyme Laboratories 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。

K172992迪亞茲美EZ維生素D測試K163418迪亞茲美DZ-Lite總β-hCG測試系統K162297迪亞茲美普羅鈣調素（PCT）測試，迪亞茲美普羅鈣調素（PCT）校准組，迪亞茲美普羅鈣調素（PCT）控制組K160762迪亞茲美直接HbA1c試驗（酵素法，內置裂解），迪亞茲美直接HbA1c試驗校准組，迪亞茲美直接HbA1c試驗控制組K153394迪亞茲美人類卡巴自由輕鏈測試，迪亞茲美人類拉馬自由輕鏈測試，迪亞茲美人類卡巴/拉馬自由輕鏈校准儀，迪亞茲美人類卡巴/拉馬自由輕鏈校准儀K161646迪亞茲美葉酸測試，迪亞茲美葉酸校準組合，迪亞茲美葉酸控制組合

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