FDA 510(k)

URight 頸部血紅素A1c系統，FORA A1c 系統

K 號：K142664 · 2016-01-29

決定日期2016-01-29

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

URight Hemoglobin A1c system, FORA A1c System is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2016-01-29 under 510(k) number K142664. 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 URight Hemoglobin A1c system, FORA A1c System?

URight Hemoglobin A1c system, FORA A1c System is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K142664.

When did URight Hemoglobin A1c system, FORA A1c System receive FDA 510(k) clearance?

URight Hemoglobin A1c system, FORA A1c System received FDA 510(k) clearance on 2016-01-29, under 510(k) number K142664.

Who is the listed applicant for URight Hemoglobin A1c system, FORA A1c System?

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

What is the FDA product code for URight Hemoglobin A1c system, FORA A1c System?

The FDA product code for URight Hemoglobin A1c system, FORA A1c System is LCP.

其他以 Taidoc Technology 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。

K221349XPER技術 PREMIUM Pro 血糖監測系統 K201037FORA先進GD40血糖、β-酮體及膽固醇監測系統 K200946Clever 頭額溫度計 / Clever 医療頭額溫度計 (型號 TD-1241)K190579TD-4183 血糖監測系統 K182934FORA P100 血壓監測系統 K180863FORA NAS100 電子鼻吸器，電子鼻吸器

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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 Corporation K231465Q-Pad測試系統Qurasense K214117Afinion™ HbA1c, Afinion™ 2 和 Alere Afinion™ AS100 分析儀Abbott Diagnostics Technologies AS K192987Aina 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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