Submission Details
| 510(k) Number | K231373 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 12, 2023 |
| Decision Date | February 02, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
K231373 is an FDA 510(k) clearance for the BD Vacutainer? K2 EDTA Blood Collection Tubes, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on February 2, 2024, 266 days after receiving the submission on May 12, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K231373 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 12, 2023 |
| Decision Date | February 02, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1675 |