K-number	K202525
Device name	Alinity i STAT High Sensitivity Troponin-I
Applicant	Abbott Laboratories Diagnostics Division
Product code	MMI
Device class	Class II
Decision date	May 19, 2022
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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Alinity i STAT High Sensitivity Troponin-I

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