FDA 510(k) Applications for Medical Device Product Code: QAT ()

FDA 510(k) Applications for Medical Device Product Code "QAT"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K201778	Abbott Laboratories	i-STAT TBI Plasma cartridge with the i-STAT Alinity System	01/08/2021
K232669	Abbott Laboratories	TBI	09/29/2023
K223602	Abbott Laboratories	Traumatic brain injury (TBI) test	03/02/2023
K234143	Abbott Point of Care	i-STAT TBI Cartridge with the i-STAT Alinity System	03/27/2024
DEN170045	Banyan Biomarkers, Inc.	Banyan BTI	02/14/2018
K240279	Biomerieux Inc.	VIDAS TBI (GFAP, UCH-L1)	05/01/2024