Clearance Summary
BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 received FDA 510(k) clearance under submission number K101502, sponsored by Becton, Dickinson & CO. 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 2010-06-29.
- Submission: K101502
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2010-06-29
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.