FDA 510(k)

i-STAT hs-TnI 芯片，适用于 i-STAT Alinity 系统

K号: K253051 · 2026-06-11

决定日期2026-06-11

产品代码MMI

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 hs-TnI cartridge with the i-STAT Alinity 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 2026-06-11 under 510(k) number K253051. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the i-STAT hs-TnI cartridge with the i-STAT Alinity System?

i-STAT hs-TnI cartridge with the i-STAT Alinity System is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K253051.

When did i-STAT hs-TnI cartridge with the i-STAT Alinity System receive FDA 510(k) clearance?

i-STAT hs-TnI cartridge with the i-STAT Alinity System received FDA 510(k) clearance on 2026-06-11, under 510(k) number K253051.

Who is the listed applicant for i-STAT hs-TnI cartridge with the i-STAT Alinity 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 hs-TnI cartridge with the i-STAT Alinity System?

The FDA product code for i-STAT hs-TnI cartridge with the i-STAT Alinity System is MMI.

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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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。