FDA 510(k)

i-STAT CG8+ 芯片，适用于 i-STAT 1 系统

K号: K230275 · 2023-10-27

决定日期2023-10-27

产品代码JGS

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 CG8+ cartridge with the i-STAT 1 System 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 2023-10-27 under 510(k) number K230275. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the i-STAT CG8+ cartridge with the i-STAT 1 System?

i-STAT CG8+ cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K230275.

When did i-STAT CG8+ cartridge with the i-STAT 1 System receive FDA 510(k) clearance?

i-STAT CG8+ cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2023-10-27, under 510(k) number K230275.

Who is the listed applicant for i-STAT CG8+ cartridge with the i-STAT 1 System?

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 CG8+ cartridge with the i-STAT 1 System?

The FDA product code for i-STAT CG8+ cartridge with the i-STAT 1 System is JGS.

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。

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官方来源

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