510(k) K222430

VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin by Biomerieux Sa, Inc. — Product Code LON

K222430 is an FDA 510(k) premarket notification submitted by Biomerieux Sa, Inc. for the device "VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin". The FDA issued a decision of Substantially Equivalent on March 9, 2023. The device falls under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation), a Class II device regulated under 21 CFR 866.1645.