Submission Details
| 510(k) Number | K213670 FDA.gov |
| FDA Decision | Cleared 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 |
K213670 is an FDA 510(k) clearance for the BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes, 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 review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K213670 FDA.gov |
| FDA Decision | Cleared 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 |