Clearance Summary
VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR received FDA 510(k) clearance under submission number K103041, sponsored by Greiner Bio-One North America, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2010-11-09.
- Submission: K103041
- Applicant / Sponsor: Greiner Bio-One North America, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2010-11-09
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.