K-number	K123947
Device name	ARCHITECT IVANCOMYCIN
Applicant	Biokit, S.A.
Product code	LEH
Device class	Class II
Decision date	Aug 29, 2013
Decision	Substantially Equivalent
Regulation	862.3950

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Source

View the full FDA submission: accessdata.fda.gov

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ARCHITECT IVANCOMYCIN

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