510(k) K213953

BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes by Becton, Dickinson and Company — Product Code JKA

K213953 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes". The FDA issued a decision of Substantially Equivalent on July 17, 2023. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.