VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE— 510(k) K981013
Substantially Equivalent for Some IndicationsBecton Dickinson Vacutainer Systems
FDA 510(k) clearance K981013 for VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE, Substantially Equivalent for Some Indications on 1998-06-17. Applicant: Becton Dickinson Vacutainer Systems.
Clearance details
- Applicant
- Becton Dickinson Vacutainer Systems
- Product code
- Code JKA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Franklin Lake, NJ, US
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
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.