Source document or public record
FDA 510(k) K223602 — Traumatic brain injury (TBI) test
FDA 510(k) index record K223602. Device: Traumatic brain injury (TBI) test. Applicant as listed: Abbott Laboratories. Decision date: 2023-03-02.
Source
"device_name": "Traumatic brain injury (TBI) test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K223602.
Device name: Traumatic brain injury (TBI) test. Applicant as listed: Abbott Laboratories.
Decision date: 2023-03-02. Decision wording: Substantially Equivalent.
Product code: QAT. Regulation: 21 CFR 866.5830. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.