K-number	K213931
Device name	VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
Applicant	bioMerieux, Inc.
Product code	LON
Device class	Class II
Decision date	Jun 3, 2022
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 Omadacycline (<=0.25 - >=16 µg/mL)

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