FDA 510(k)

ARCHITECT STAT高敏肌钙蛋白-I

K号: K191595 · 2019-09-13

申请人Abbott Laboratories Diagnostics Division

决定日期2019-09-13

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

ARCHITECT 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 2019-09-13 under 510(k) number K191595. 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 ARCHITECT STAT High Sensitivity Troponin-I?

ARCHITECT STAT High Sensitivity Troponin-I is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Abbott Laboratories Diagnostics Division. The 510(k) number is K191595.

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

ARCHITECT STAT High Sensitivity Troponin-I received FDA 510(k) clearance on 2019-09-13, under 510(k) number K191595.

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

The FDA product code for ARCHITECT 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 K202525Alinity i STAT高敏肌钙蛋白I

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。