K-number	K191595
Device name	ARCHITECT STAT High Sensitivity Troponin-I
Applicant	Abbott Laboratories Diagnostics Division
Product code	MMI
Device class	Class II
Decision date	Sep 13, 2019
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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ARCHITECT STAT High Sensitivity Troponin-I

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