K-number	K162606
Device name	Elecsys TSH assay, cobas e 801 Immunoassay analyzer
Applicant	Roche Diagnostics
Product code	JLW
Device class	Class II
Decision date	Jan 23, 2017
Decision	Substantially Equivalent
Regulation	862.1690

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Source

View the full FDA submission: accessdata.fda.gov

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Elecsys TSH assay, cobas e 801 Immunoassay analyzer

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