Tru Hematology Test— 510(k) K251249

Substantially Equivalent

Truvian Sciences, Inc.

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

Clearance details

Applicant: Truvian Sciences, Inc.
Product code: Code GKZ
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 ↗

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.