K-number	K211136
Device name	VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
Applicant	bioMerieux, Inc.
Product code	LON
Device class	Class II
Decision date	Jun 14, 2021
Decision	Substantially Equivalent
Regulation	866.1645

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View the full FDA submission: accessdata.fda.gov

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VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)

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