K-number	K220805
Device name	VITEK 2 AST-Gram Positive Cefoxitin Screen
Applicant	bioMerieux, Inc.
Product code	LON
Device class	Class II
Decision date	Oct 13, 2022
Decision	Substantially Equivalent
Regulation	866.1645

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Source

View the full FDA submission: accessdata.fda.gov

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VITEK 2 AST-Gram Positive Cefoxitin Screen

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