Tru Hematology Test— 510(k) K251249

Name: FDA 510(k) clearance K251249
Creator: U.S. Food and Drug Administration
Published: 2026-01-16

Substantially Equivalent

Truvian Sciences, Inc.

FDA 510(k) clearance K251249 for Tru Hematology Test, Substantially Equivalent on 2026-01-16. Applicant: Truvian Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Truvian Sciences, Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2025-04-23
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKZ

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K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers2026-05-27
K243348 — Athelas Home2026-02-06
K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer2025-06-25
K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer2025-06-25
K243283 — Alinity h-series System2025-02-20

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.