510(k) K120994

BD BACTEC Plus PRIME Aerobic/F Culture Vials by Becton, Dickinson and Company — Product Code MDB

K120994 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD BACTEC Plus PRIME Aerobic/F Culture Vials". The FDA issued a decision of Substantially Equivalent on August 7, 2012. The device falls under product code MDB (System, Blood Culturing), a Class I device regulated under 21 CFR 866.2560. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.