FDA 510(k)

鎂

K 號：K181748 · 2018-09-12

決定日期2018-09-12

產品代碼JGJ

諮詢委員會CH

決定相當於

器材摘要

Magnesium is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2018-09-12 under 510(k) number K181748. 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 Magnesium?

Magnesium is a medical device that received FDA 510(k) clearance on 2018-09-12. The listed applicant is Abbott Laboratories. The 510(k) number is K181748.

When did Magnesium receive FDA 510(k) clearance?

Magnesium received FDA 510(k) clearance on 2018-09-12, under 510(k) number K181748.

Who is the listed applicant for Magnesium?

FDA 510(k) 記錄中將阿培爾實驗室列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Magnesium?

The FDA product code for Magnesium is JGJ.

其他以 Abbott Laboratories 為申請人之記錄

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K262156Anti-HCV Next K252424Anti-HCV Next K243500ARCHITECT庆大霉素 K243168Alinity i 飛蚊症IgG K243283Alinity h-series 系統 K233932Alinity i Toxo IgM

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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。

K173294鎂Abbott Laboratories K162200Randox RX Daytona Plus 镁 (MG)Randox Laboratories, Ltd.K162399Atellica CH 鎂 (Mg)Siemens Healthcare Diagnostics, Inc.

官方來源

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