Tru Hematology Test
FDA 510(k) clearance K251249 · decided 2026-01-16
Clearance details
- K-number
- K251249
- Device name
- Tru Hematology Test
- Applicant
- Truvian Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-23
- Decision date
- 2026-01-16
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.