Traumatic brain injury (TBI) test— 510(k) K223602

Name: FDA 510(k) clearance K223602
Creator: U.S. Food and Drug Administration
Published: 2023-03-02

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K223602 for Traumatic brain injury (TBI) test, Substantially Equivalent on 2023-03-02. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code QAT
Device class: Class 2
Regulation: 21 CFR 866.5830
Advisory panel: Immunology
Date received: 2022-12-02
Decision date: 2023-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.