K-number	K222610
Device name	Elecsys Anti-Tg
Applicant	Roche Diagnostics
Product code	JZO
Device class	Class II
Decision date	Sep 15, 2023
Decision	Substantially Equivalent
Regulation	866.5870

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Source

View the full FDA submission: accessdata.fda.gov

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Elecsys Anti-Tg

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