BD BACTEC FXI Culture System— 510(k) K260213
Substantially EquivalentBD Diagnostic Systems
FDA 510(k) clearance K260213 for BD BACTEC FXI Culture System, Substantially Equivalent on 2026-05-28. Applicant: BD Diagnostic Systems.
Clearance details
- Applicant
- BD Diagnostic Systems
- Product code
- Code MDB
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Adverse events under product code MDB
product code MDB- Death
- 6
- Malfunction
- 5,490
- Total
- 5,496
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.