K260213
- 510(k) number
- K260213
- Device name
- BD BACTEC FXI Culture System
- Applicant
- BD Diagnostic Systems MD · US
- Product code
- MDB — System, Blood Culturing
- Decision date
- 2026-05-28
- Date received
- 2026-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K260213.pdf
Official FDA record: K260213
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.