K-number	K230161
Device name	ONLINE TDM Phenytoin - Free Phenytoin application
Applicant	Roche Diagnostics
Product code	MOJ
Device class	Class II
Decision date	Mar 30, 2023
Decision	Substantially Equivalent
Regulation	862.3350

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Source

View the full FDA submission: accessdata.fda.gov

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ONLINE TDM Phenytoin - Free Phenytoin application

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