K-number	K234143
Device name	i-STAT TBI Cartridge with the i-STAT Alinity System
Applicant	Abbott Point of Care
Product code	QAT
Device class	Class II
Decision date	Mar 27, 2024
Decision	Substantially Equivalent
Regulation	866.5830

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Source

View the full FDA submission: accessdata.fda.gov

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i-STAT TBI Cartridge with the i-STAT Alinity System

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