QBC ACCUTUBE— 510(k) K945205
Substantially EquivalentBecton Dickinson Diagnostic Instrument Systems
FDA 510(k) clearance K945205 for QBC ACCUTUBE, Substantially Equivalent on 1995-09-25. Applicant: Becton Dickinson Diagnostic Instrument Systems.
Clearance details
- Applicant
- Becton Dickinson Diagnostic Instrument Systems
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
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.