FDA 510(k)

i-Stat Alinity系统，配备i-Stat血糖测试

K号: K163271 · 2017-04-10

决定日期2017-04-10

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

i-Stat Alinity System with i-Stat Glucose test is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2017-04-10 under 510(k) number K163271. 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 i-Stat Alinity System with i-Stat Glucose test?

i-Stat Alinity System with i-Stat Glucose test is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K163271.

When did i-Stat Alinity System with i-Stat Glucose test receive FDA 510(k) clearance?

i-Stat Alinity System with i-Stat Glucose test received FDA 510(k) clearance on 2017-04-10, under 510(k) number K163271.

Who is the listed applicant for i-Stat Alinity System with i-Stat Glucose test?

The FDA 510(k) record lists Abbott Point of Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-Stat Alinity System with i-Stat Glucose test?

The FDA product code for i-Stat Alinity System with i-Stat Glucose test is CGA.

列明Abbott Point of Care, Inc.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。

K261039i-STAT Crea胶囊与i-STAT 1系统 K253051i-STAT hs-TnI 芯片，适用于 i-STAT Alinity 系统 K244014i-STAT CG4+ 芯片，适用于 i-STAT 1 系统 K240984i-STAT hs-TnI 芯片与 i-STAT 1 系统 K230275i-STAT CG8+ 芯片，适用于 i-STAT 1 系统 K230285i-STAT CG8+ 芯片，适用于 i-STAT 1 系统

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