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

Substantially Equivalent

Abbott Laboratories

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

Clearance details

Applicant: Abbott Laboratories
Product code: Code QAT
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 ↗

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