SCEPTOR DATA MANAGEMENT CENTER SOFTWARE— 510(k) K891577
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K891577 for SCEPTOR DATA MANAGEMENT CENTER SOFTWARE, Substantially Equivalent on 1989-06-02. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic.
Clearance details
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Product code
- Code LON
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
Adverse events under product code LON
product code LON- Malfunction
- 2,383
- Total
- 2,383
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.