Clearance Summary
VACUETTE EDTA K2 TUBES received FDA 510(k) clearance under submission number K014104, sponsored by Greiner Vacuette North America, Inc.. 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 2002-02-01.
- Submission: K014104
- Applicant / Sponsor: Greiner Vacuette North America, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2002-02-01
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.