VACUTAINER BRAND PPT PLASMA PREPARATION TUBE— 510(k) K972075
Substantially EquivalentBecton Dickinson Vacutainer Systems
FDA 510(k) clearance K972075 for VACUTAINER BRAND PPT PLASMA PREPARATION TUBE, Substantially Equivalent on 1998-02-24. Applicant: Becton Dickinson Vacutainer Systems.
Clearance details
- Applicant
- Becton Dickinson Vacutainer Systems
- Product code
- Code PJE
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lake, NJ, US
Adverse events under product code PJE
product code PJE- Malfunction
- 540
- Total
- 540
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.