FDA 510(k)

Randox RX Daytona Plus 镁 (MG)

K 號：K162200 · 2017-04-28

決定日期2017-04-28

產品代碼JGJ

諮詢委員會CH

決定相當於

器材摘要

Randox RX Daytona Plus Magnesium (MG) 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 2017-04-28 under 510(k) number K162200. The device is classified under product code JGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Randox RX Daytona Plus Magnesium (MG)?

Randox RX Daytona Plus Magnesium (MG) is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K162200.

When did Randox RX Daytona Plus Magnesium (MG) receive FDA 510(k) clearance?

Randox RX Daytona Plus Magnesium (MG) received FDA 510(k) clearance on 2017-04-28, under 510(k) number K162200.

Who is the listed applicant for Randox RX Daytona Plus Magnesium (MG)?

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 Randox RX Daytona Plus Magnesium (MG)?

The FDA product code for Randox RX Daytona Plus Magnesium (MG) is JGJ.

其他以 Randox Laboratories, Ltd. 為申請人之記錄

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相關器械（代碼：JGJ）

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。

K181748鎂Abbott Laboratories K173294鎂Abbott Laboratories K162399Atellica CH 鎂 (Mg)Siemens Healthcare Diagnostics, Inc.

官方來源

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