510(k) K260619

VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) by Biomérieux, Inc. — Product Code LON

K260619 is an FDA 510(k) premarket notification submitted by Biomérieux, Inc. for the device "VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)". The FDA issued a decision of Substantially Equivalent on Sep 28, 2026. The device falls under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation), a Class II device regulated under 21 CFR 866.1645. Biomérieux, Inc. has 6 other 510(k) clearances on record.