K231282 is an FDA 510(k) clearance for the LifeOutcomes C-Quest™ Blood Culture Sampling Device. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Lifeoutcomes, LLC (Englewood, US). The FDA issued a Cleared decision on January 26, 2024, 268 days after receiving the submission on May 3, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K231282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2023 |
| Decision Date | January 26, 2024 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| 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 |