K-number	K183678
Device name	i-STAT CHEM8+ cartridge with the i-STAT 1 System
Applicant	Abbott Point of Care, Inc.
Product code	CGA
Device class	Class II
Decision date	Feb 7, 2020
Decision	Substantially Equivalent
Regulation	862.1345

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View the full FDA submission: accessdata.fda.gov

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i-STAT CHEM8+ cartridge with the i-STAT 1 System

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