510(k) K220803

VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin by bioMerieux, Inc. — Product Code LON

K220803 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin". The FDA issued a decision of Substantially Equivalent on January 27, 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. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.