510(k) K213670
K213670 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes". The FDA issued a decision of Substantially Equivalent on August 25, 2023. 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
- August 25, 2023
- Date Received
- November 22, 2021
- 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