Source document or public record
FDA 510(k) K251249 — Tru Hematology Test
FDA 510(k) index record K251249. Device: Tru Hematology Test. Applicant as listed: Truvian Sciences, Inc.. Decision date: 2026-01-16.
Source
"device_name": "Tru Hematology Test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K251249.
Device name: Tru Hematology Test. Applicant as listed: Truvian Sciences, Inc..
Decision date: 2026-01-16. Decision wording: Substantially Equivalent.
Product code: GKZ. Regulation: 21 CFR 864.5220. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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