FDA 510(k)

直接高密度膽固醇（HDL）

K 號：K153435 · 2016-01-08

決定日期2016-01-08

產品代碼LBS

諮詢委員會CH

決定相當於

器材摘要

Direct HDL Cholesterol (HDL) is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2016-01-08 under 510(k) number K153435. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Direct HDL Cholesterol (HDL)?

Direct HDL Cholesterol (HDL) is a medical device that received FDA 510(k) clearance on 2016-01-08. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K153435.

When did Direct HDL Cholesterol (HDL) receive FDA 510(k) clearance?

Direct HDL Cholesterol (HDL) received FDA 510(k) clearance on 2016-01-08, under 510(k) number K153435.

Who is the listed applicant for Direct HDL Cholesterol (HDL)?

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

What is the FDA product code for Direct HDL Cholesterol (HDL)?

The FDA product code for Direct HDL Cholesterol (HDL) is LBS.

其他以 Randox Laboratories, Ltd. 為申請人之記錄

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K230890ISE電極 K182042Randox 钙（Ca）K162200Randox RX Daytona Plus 镁 (MG)K152085液態二氧化碳-2（LCO2-2）

相關器械（代碼：LBS）

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。

K162593HDL-膽固醇 Gen.4Roche Diagnostics Operations (Rdo)

官方來源

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