K240455 is an FDA 510(k) clearance for the BD Vacutainer® Citrate 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 October 31, 2024, 259 days after receiving the submission on February 15, 2024.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K240455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2024 |
| Decision Date | October 31, 2024 |
| Days to Decision | 259 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 |