510(k) K230493
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube by
Becton, Dickinson and Company
— Product Code GIM
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2023
- Date Received
- February 23, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vacuum Sample, With Anticoagulant
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type