K251249 is an FDA 510(k) clearance for the Tru Hematology Test. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Truvian Sciences, Inc. (San Diego, US). The FDA issued a Cleared decision on January 16, 2026, 268 days after receiving the submission on April 23, 2025.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K251249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2025 |
| Decision Date | January 16, 2026 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKZ - Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |