DeviceClearance

K042927

Substantially Equivalent

VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES

Applicant
Greiner Bio-One Vacuette North America
Product code
PJE
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Baldwin, MD, US
Download summary PDF View on FDA.gov ↗

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.