Tru Hematology Test

FDA 510(k) K251249 · Truvian Sciences, Inc.

Substantially Equivalent

510(k) numberK251249

Submission

Device name
Tru Hematology Test
Applicant
Truvian Sciences, Inc.
San Diego, CA, US
Received
April 23, 2025
Decision date
January 16, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GKZ – Counter, Differential Cell
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5220
Specialty
Hematology

Other 510(k)s with product code GKZ

510(k)DeviceApplicantDecision
K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional Sysmex America, Inc.05/27/2026SE
K243348Athelas HomeGKZ · Traditional Athelas, Inc.02/06/2026SE
K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional Sysmex America, Inc.06/25/2025SE
K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional Sysmex America, Inc.06/25/2025SE
K243283Alinity h-series SystemGKZ · Traditional Abbott Laboratories02/20/2025SE
K240402Cito CBC SystemGKZ · Dual Track Cytochip, Inc.02/03/2025SE
K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…GKZ · Traditional Beckman Coulter, Inc.07/05/2024SE
K232946Yumizen H2500GKZ · Traditional Horiba Abx SAS05/21/2024SE
K240636HemoScreen Hematology AnalyzerGKZ · Abbreviated Pixcell Medical Technologies05/02/2024SE
K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ · Traditional Sysmex America, Inc.12/21/2023SE

Questions and answers

When was Tru Hematology Test cleared by the FDA?

Tru Hematology Test (K251249) received a 510(k) decision of Substantially Equivalent on January 16, 2026, 268 days after the submission was received.

What is the product code of K251249?

The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.