K-number	K152245
Device name	ONLINE TDM Vancomycin Gen.3
Applicant	Roche Diagnostics Operations (Rdo)
Product code	LEH
Device class	Class II
Decision date	Jan 8, 2016
Decision	Substantially Equivalent
Regulation	862.3950

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Source

View the full FDA submission: accessdata.fda.gov

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ONLINE TDM Vancomycin Gen.3

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