Clearance Summary
VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES received FDA 510(k) clearance under submission number K042927, sponsored by Greiner Bio-One Vacuette North America. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2005-04-15.
- Submission: K042927
- Applicant / Sponsor: Greiner Bio-One Vacuette North America
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2005-04-15
Classification & Regulation
This clearance is catalogued under FDA product code PJE and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.