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FDA 510(k)

skyla 高血糖化血红蛋白A1c系統（skyla Hi 分析儀及skyla Hi 血糖化血红蛋白A1c試劑組）

K 號：K173127 · 2018-09-25

申請人Skyla Corporation H.S.P.B
決定日期2018-09-25
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

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) is the device name listed in this FDA 510(k) record. The listed applicant is Skyla Corporation H.S.P.B. It received FDA 510(k) clearance on 2018-09-25 under 510(k) number K173127. 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 skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)?

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) is a medical device that received FDA 510(k) clearance on 2018-09-25. The listed applicant is Skyla Corporation H.S.P.B. The 510(k) number is K173127.

When did skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) receive FDA 510(k) clearance?

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) received FDA 510(k) clearance on 2018-09-25, under 510(k) number K173127.

Who is the listed applicant for skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)?

The FDA 510(k) record lists Skyla Corporation H.S.P.B as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)?

The FDA product code for skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) is LCP.

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

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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