K-number	K223602
Device name	Traumatic brain injury (TBI) test
Applicant	Abbott Laboratories
Product code	QAT
Device class	Class II
Decision date	Mar 2, 2023
Decision	Substantially Equivalent
Regulation	866.5830

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Source

View the full FDA submission: accessdata.fda.gov

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Traumatic brain injury (TBI) test

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