BD BACTEC Plus Aerobic/F Culture Vials— 510(k) K083572
Substantially EquivalentBecton, Dickinson & CO
FDA 510(k) clearance K083572 for BD BACTEC Plus Aerobic/F Culture Vials, Substantially Equivalent on 2008-12-24. Applicant: Becton, Dickinson & CO.
Clearance details
- Applicant
- Becton, Dickinson & CO
- Product code
- Code MDB
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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.