510(k) K113558

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

K113558 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD BACTEC Plus Aerobic/F Culture Vials (plastic)". The FDA issued a decision of Substantially Equivalent on March 16, 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.