K213670 is an FDA 510(k) clearance for the BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes. This device is classified as a Tubes, Vacuum Sample, With Anticoagulant (Class II - Special Controls, product code GIM).
Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on August 25, 2023, 641 days after receiving the submission on November 22, 2021.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K213670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2021 |
| Decision Date | August 25, 2023 |
| Days to Decision | 641 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GIM — Tubes, Vacuum Sample, With Anticoagulant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |