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FDA 510(k)

Tru Hematology Test

K-Number: K251249 · 2026-01-16

ApplicantTruvian Sciences, Inc.
Decision Date2026-01-16
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Tru Hematology Test is a medical device manufactured by Truvian Sciences, Inc.. It received FDA 510(k) clearance on 2026-01-16 under approval 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. It is manufactured by Truvian Sciences, Inc.. The 510(k) number is K251249.

When was Tru Hematology Test approved by the FDA?

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

What company makes Tru Hematology Test?

Tru Hematology Test is manufactured by Truvian Sciences, Inc..

What is the FDA product code for Tru Hematology Test?

The FDA product code for Tru Hematology Test is GKZ.

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Official Source

View on FDA Database →

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

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