510(k) K161810

BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial by Becton Dickinson — Product Code MDB

K161810 is an FDA 510(k) premarket notification submitted by Becton Dickinson for the device "BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial". The FDA issued a decision of Substantially Equivalent on February 9, 2017. The device falls under product code MDB (System, Blood Culturing), a Class I device regulated under 21 CFR 866.2560. Becton Dickinson has at least 5 other 510(k) clearances on record.