Name: Predicase
Price: 199 USD

K-number	K222430
Device name	VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
Applicant	Biomerieux Sa, Inc.
Product code	LON
Device class	Class II
Decision date	Mar 9, 2023
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 Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin

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