FDA 510(k)

使命膽固醇監測系統，使命膽固醇專業監測系統

K 號：K163406 · 2017-07-11

決定日期2017-07-11

產品代碼CHH

諮詢委員會CH

決定相當於

器材摘要

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K163406. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System?

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K163406.

When did Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System receive FDA 510(k) clearance?

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System received FDA 510(k) clearance on 2017-07-11, under 510(k) number K163406.

Who is the listed applicant for Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System?

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

What is the FDA product code for Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System?

The FDA product code for Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System is CHH.

其他以 ACON Laboratories, Inc. 為申請人之記錄

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K261212Flowflex Plus RSV + 流行性感冒A/B + COVID 快速檢測 K251697Flowflex® Plus 醍醐A 快速測試條；Flowflex® Plus 醍醐A 快速測試卡 K251749Flowflex Plus RSV + 流行性感冒A/B + COVID家庭檢測 K250085On Call® 確保 GK 血糖與酮體監測系統；On Call® 確保同步 GK 血糖與酮體監測系統 K250377Flowflex Plus COVID-19 + 流感A/B 家庭檢測 K232715Distinct®數位懷孕檢測器

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相關器械（代碼：CHH）

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。

K251091脂質Truvian Health K232404膽固醇；高密度膽固醇；低密度膽固醇；三酸甘油脂Medicon Hellas S.A K203597膽固醇2Abbott Ireland Diagnostics Division K190490VITROS XT 化學產品 TRIG-CHOL 製品Ortho-Clinical Diagnostics, Inc.K181373延長脂質面板測試Laboratory Corporation of America Holdings K180504使命脂質面板監測系統ACON Laboratories, Inc.

官方來源

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