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FDA 510(k)

Traumatic brain injury (TBI) test

K-Number: K223602 · 2023-03-02

ApplicantAbbott Laboratories
Decision Date2023-03-02
Product CodeQAT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Abbott Laboratories. The 510(k) number is K223602.

When was Traumatic brain injury (TBI) test approved by the FDA?

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

What company makes Traumatic brain injury (TBI) test?

Traumatic brain injury (TBI) test is manufactured by Abbott Laboratories.

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

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

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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