FDA 510(k)

液態二氧化碳-2（LCO2-2）

K 號：K152085 · 2016-02-24

決定日期2016-02-24

產品代碼KHS

諮詢委員會CH

決定相當於

器材摘要

Liquid CO2-2 (LCO2-2) 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 2016-02-24 under 510(k) number K152085. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Liquid CO2-2 (LCO2-2)?

Liquid CO2-2 (LCO2-2) is a medical device that received FDA 510(k) clearance on 2016-02-24. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K152085.

When did Liquid CO2-2 (LCO2-2) receive FDA 510(k) clearance?

Liquid CO2-2 (LCO2-2) received FDA 510(k) clearance on 2016-02-24, under 510(k) number K152085.

Who is the listed applicant for Liquid CO2-2 (LCO2-2)?

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 Liquid CO2-2 (LCO2-2)?

The FDA product code for Liquid CO2-2 (LCO2-2) is KHS.

其他以 Randox Laboratories, Ltd. 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。

K230890ISE電極 K182042Randox 钙（Ca）K162200Randox RX Daytona Plus 镁 (MG)K153435直接高密度膽固醇（HDL）

相關器械（代碼：KHS）

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。

K170200二氧化碳試劑組Teco Diagnostics, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。