ClearanceBrief
510(k) K260213 ยท MDB System, Blood Culturing

BD BACTEC FXI Culture System

ApplicantBD Diagnostic Systems, Sparks MD, US
DecisionSubstantially Equivalent, May 28, 2026
ReceivedJan 23, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260213

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.