510(k) K230391
K230391 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube". The FDA issued a decision of Substantially Equivalent on December 1, 2023. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2023
- Date Received
- February 14, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type