BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS— 510(k) K954921
Substantially EquivalentBecton Dickinson Diagnostic Instrument Systems
FDA 510(k) clearance K954921 for BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS, Substantially Equivalent on 1996-02-16. Applicant: Becton Dickinson Diagnostic Instrument Systems.
Clearance details
- Applicant
- Becton Dickinson Diagnostic Instrument 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.