FDA 510(k) Application Details - K223602

Device Classification Name	More FDA Info for this Device
510(K) Number	K223602
Device Name	Traumatic brain injury (TBI) test
Applicant	Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064 US Other 510(k) Applications for this Company
Contact	Lisa Kelly Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2022
Decision Date	03/02/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review