FDA 510(k)

Alinity i STAT高敏肌钙蛋白I

K号: K202525 · 2022-05-19

申请人Abbott Laboratories Diagnostics Division

决定日期2022-05-19

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

Alinity i STAT High Sensitivity Troponin-I is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories Diagnostics Division. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K202525. 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 Alinity i STAT High Sensitivity Troponin-I?

Alinity i STAT High Sensitivity Troponin-I is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Abbott Laboratories Diagnostics Division. The 510(k) number is K202525.

When did Alinity i STAT High Sensitivity Troponin-I receive FDA 510(k) clearance?

Alinity i STAT High Sensitivity Troponin-I received FDA 510(k) clearance on 2022-05-19, under 510(k) number K202525.

Who is the listed applicant for Alinity i STAT High Sensitivity Troponin-I?

The FDA 510(k) record lists Abbott Laboratories Diagnostics Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alinity i STAT High Sensitivity Troponin-I?

The FDA product code for Alinity i STAT High Sensitivity Troponin-I is MMI.

列明Abbott Laboratories Diagnostics Division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。

K240468碱性磷酸酶 K230994Alinity i STAT高敏肌钙蛋白I K191595ARCHITECT STAT高敏肌钙蛋白-I

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