FDA.report

510(k) K251249

Device
Tru Hematology Test
Applicant
Truvian Sciences, Inc.
510(k) number
K251249
Product code
GKZ
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-16
Date received
2025-04-23
Regulation
864.5220
Classification name
Counter, Differential Cell
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Tho Tran
Address
10300 Campus Pt. Dr. Suite 190 San Diego CA US 92121 92121

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K210346Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc.2022-11-08
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