FDA 510(k)

GEM Premier 5000（測量參數：葡萄糖、乳酸及總膽紅素）

K 號：K160402 · 2016-12-14

決定日期2016-12-14

產品代碼CGA

諮詢委員會CH

決定相當於

器材摘要

GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K160402. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)?

GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K160402.

When did GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) receive FDA 510(k) clearance?

GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) received FDA 510(k) clearance on 2016-12-14, under 510(k) number K160402.

Who is the listed applicant for GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)?

The FDA product code for GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) is CGA.

其他以 Instrumentation Laboratory CO 為申請人之記錄

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相關器械（代碼：CGA）

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。

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