VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES— 510(k) K042927
Substantially EquivalentGreiner Bio-One Vacuette North America
FDA 510(k) clearance K042927 for VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES, Substantially Equivalent on 2005-04-15. Applicant: Greiner Bio-One Vacuette North America.
Clearance details
- Applicant
- Greiner Bio-One Vacuette North America
- Product code
- Code PJE
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baldwin, MD, 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.