FDA 510(k)

Tru Hematology Test

K-Number: K251249 · 2026-01-16

Decision Date2026-01-16

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Tru Hematology Test is the device name listed in this FDA 510(k) record. The listed applicant is Truvian Sciences, Inc.. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K251249. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tru Hematology Test?

Tru Hematology Test is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Truvian Sciences, Inc.. The 510(k) number is K251249.

When did Tru Hematology Test receive FDA 510(k) clearance?

Tru Hematology Test received FDA 510(k) clearance on 2026-01-16, under 510(k) number K251249.

Who is the listed applicant for Tru Hematology Test?

The FDA 510(k) record lists Truvian Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tru Hematology Test?

The FDA product code for Tru Hematology Test is GKZ.

Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K243283Alinity h-series SystemAbbott Laboratories K240402Cito CBC SystemCytochip, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.