Name: Predicase
Price: 199 USD

K-number	K213241
Device name	VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
Applicant	bioMerieux, Inc.
Product code	LON
Device class	Class II
Decision date	Feb 25, 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-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole

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