Clearance Summary
BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 received FDA 510(k) clearance under submission number K093972, sponsored by Becton, Dickinson & CO. 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 2010-01-21.
- Submission: K093972
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2010-01-21
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.