FDA 510(k)

膽固醇2

K 號：K203597 · 2022-06-30

決定日期2022-06-30

產品代碼CHH

諮詢委員會CH

決定相當於

器材摘要

Cholesterol2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K203597. 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 Cholesterol2?

Cholesterol2 is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K203597.

When did Cholesterol2 receive FDA 510(k) clearance?

Cholesterol2 received FDA 510(k) clearance on 2022-06-30, under 510(k) number K203597.

Who is the listed applicant for Cholesterol2?

The FDA 510(k) record lists Abbott Ireland Diagnostics Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cholesterol2?

The FDA product code for Cholesterol2 is CHH.

其他以 Abbott Ireland Diagnostics Division 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。

K223317鹼性磷酸鹽2 K223324總膽紅素2 K203771烏拉素氮含量2 K210633Amylase2 K210452肌酐2 K203530Albumin BCP2

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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 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.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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