510(k) K240455
K240455 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Vacutainer® Citrate Blood Collection Tubes". The FDA issued a decision of Substantially Equivalent on October 31, 2024. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), 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
- October 31, 2024
- Date Received
- February 15, 2024
- 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