510(k) K213953
BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes by
Becton, Dickinson and Company
— Product Code JKA
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2023
- Date Received
- December 17, 2021
- 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