510(k) K202446
K202446 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Preset Syringe & BD A-Line Syringe". The FDA issued a decision of Substantially Equivalent on Sep 25, 2020. 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 329 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 25, 2020
- Date Received
- Aug 26, 2020
- Clearance Type
- Special
- 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
- 510(k)