K-number	K230937
Device name	Alinity i Total ß-hCG Reagent Kit, GLP systems Track
Applicant	Abbott Laboratories
Product code	DHA
Device class	Class II
Decision date	Jun 5, 2023
Decision	Substantially Equivalent
Regulation	862.1155

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View the full FDA submission: accessdata.fda.gov

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Alinity i Total ß-hCG Reagent Kit, GLP systems Track

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