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FDA 510(k)

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

K 號：K160762 · 2016-11-21

申請人Diazyme Laboratories
決定日期2016-11-21
產品代碼LCP
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 Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay 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 2016-11-21 under 510(k) number K160762. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set?

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Diazyme Laboratories. The 510(k) number is K160762.

When did Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set receive FDA 510(k) clearance?

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set received FDA 510(k) clearance on 2016-11-21, under 510(k) number K160762.

Who is the listed applicant for Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay 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 Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set?

The FDA product code for Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set is LCP.

相關臨床試驗

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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K161721迪亞茲美維生素B12測試，迪亞茲美維生素B12校准器組，迪亞茲美維生素B12控制組

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相關器械（代碼：LCP）

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。

K221326諾瓦阿萊格羅HbA1c檢測，諾瓦阿萊格羅分析儀Nova Biomedical CorporationK231465Q-Pad測試系統QurasenseK214117Afinion™ HbA1c, Afinion™ 2 和 Alere Afinion™ AS100 分析儀Abbott Diagnostics Technologies ASK192987Aina HbA1c 监测系统 2Jana Care, Inc.K192369PixoTest POCT 系統 - PixoTest POCT 分析儀及 PixoTest A1c 檢測套件Ixensor Co, Ltd.K183230OneDraw A1C測試系統Drawbridge Health, Inc.

官方來源

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