Cleared Traditional

Tru Hematology Test

K251249 · Truvian Sciences, Inc. · Hematology

Jan 2026

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K251249 is an FDA 510(k) clearance for the Tru Hematology Test, 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 review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K251249 FDA.gov
FDA Decision	Cleared 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