510(k) K173523

BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) by Becton, Dickinson And Company — Product Code LON

K173523 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)". The FDA issued a decision of Substantially Equivalent on Feb 9, 2018. The device falls under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation), a Class II device regulated under 21 CFR 866.1645. Becton, Dickinson And Company has 329 other 510(k) clearances on record.