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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
DEN170045
Banyan Biomarkers, Inc.
Banyan BTI
02/14/2018
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