K-number	K162678
Device name	Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
Applicant	Roche Diagnostics
Product code	LGD
Device class	Class II
Decision date	Jun 23, 2017
Decision	Substantially Equivalent
Regulation	866.3780

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Source

View the full FDA submission: accessdata.fda.gov

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Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl

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