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FDA 510(k)

膽固醇；高密度膽固醇；低密度膽固醇；三酸甘油脂

K 號：K232404 · 2024-08-09

申請人Medicon Hellas S.A
決定日期2024-08-09
產品代碼CHH
諮詢委員會CH
決定相當於

器材摘要

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES is the device name listed in this FDA 510(k) record. The listed applicant is Medicon Hellas S.A. It received FDA 510(k) clearance on 2024-08-09 under 510(k) number K232404. 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 CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES?

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES is a medical device that received FDA 510(k) clearance on 2024-08-09. The listed applicant is Medicon Hellas S.A. The 510(k) number is K232404.

When did CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES receive FDA 510(k) clearance?

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES received FDA 510(k) clearance on 2024-08-09, under 510(k) number K232404.

Who is the listed applicant for CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES?

The FDA 510(k) record lists Medicon Hellas S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES?

The FDA product code for CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES is CHH.

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 Medicon Hellas S.A 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。

K200898Medicon Hellas 藻膠蛋白，Medicon Hellas 钙，Medicon Hellas 肌酸酐，Medicon Hellas 尿素氮，Medicon Hellas 葡萄糖，Medicon Hellas 全總膽紅素，Medicon Hellas 直接膽紅素

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 HealthK203597膽固醇2Abbott Ireland Diagnostics DivisionK190490VITROS 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 HoldingsK180504使命脂質面板監測系統ACON Laboratories, Inc.K163406使命膽固醇監測系統，使命膽固醇專業監測系統ACON Laboratories, Inc.

官方來源

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