K-number	K153301
Device name	Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
Applicant	Roche Diagnostics
Product code	KXT
Device class	Class II
Decision date	Apr 8, 2016
Decision	Substantially Equivalent
Regulation	862.3320

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View the full FDA submission: accessdata.fda.gov

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Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

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