K-number	K201675
Device name	VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
Applicant	bioMerieux, Inc.
Product code	LON
Device class	Class II
Decision date	Jul 9, 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 Meropenem (<= 0.25 - >=16 µg/mL)

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