K-number	K201441
Device name	Elecsys Troponin T Gen 5
Applicant	Roche Diagnostics
Product code	MMI
Device class	Class II
Decision date	Sep 21, 2021
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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Elecsys Troponin T Gen 5

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