510(k) K163637

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) by Becton Dickinson & Company — Product Code LON

K163637 is an FDA 510(k) premarket notification submitted by Becton Dickinson & Company for the device "BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)". The FDA issued a decision of Substantially Equivalent on March 21, 2017. 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 & Company has at least 2 other 510(k) clearances on record.