FDA 510(k)

脑外伤（TBI）测试

K号: K223602 · 2023-03-02

决定日期2023-03-02

产品代码QAT

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决定实质等同

器械摘要

Traumatic brain injury (TBI) test is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K223602. The device is classified under product code QAT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Traumatic brain injury (TBI) test?

Traumatic brain injury (TBI) test is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Abbott Laboratories. The 510(k) number is K223602.

When did Traumatic brain injury (TBI) test receive FDA 510(k) clearance?

Traumatic brain injury (TBI) test received FDA 510(k) clearance on 2023-03-02, under 510(k) number K223602.

Who is the listed applicant for Traumatic brain injury (TBI) test?

FDA 510(k)记录显示，申请人为阿伯特实验室。这本身并不能确立该设备的制造商。

What is the FDA product code for Traumatic brain injury (TBI) test?

The FDA product code for Traumatic brain injury (TBI) test is QAT.

列明Abbott Laboratories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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