FDA 510(k)

GEM Premier 5000（测量参数：葡萄糖、乳酸和总胆红素）

K号: K160402 · 2016-12-14

决定日期2016-12-14

产品代码CGA

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Instrumentation Laboratory CO为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K221359ACL TOP 970 CL, HemosIL CL 抗心磷脂IgM, HemosIL CL 抗ß2 糖蛋白-I IgM K223187HemosIL 液体抗-Xa K223090GEM Premier ChemSTAT K223402HemosIL von Willebrand 因子抗原 K213464HemosIL 液体抗-Xa K213426HemosIL ReadiPlasTin

查看所有 25 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。