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GKZ — Counter, Differential Cell Class II

FDA Device Classification

Classification Details

Product Code
GKZ
Device Class
Class II
Regulation Number
864.5220
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243348athelasAthelas HomeFebruary 6, 2026
K251249truvian sciencesTru Hematology TestJanuary 16, 2026
K250943sysmex americaSysmex XR-Series (XR-10) Automated Hematology AnalyzerJune 25, 2025
K251371sysmex americaSysmex XR-Series (XR-20) Automated Hematology AnalyzerJune 25, 2025
K243283abbott laboratoriesAlinity h-series SystemFebruary 20, 2025
K240402cytochipCito CBC SystemFebruary 3, 2025
K240252beckman coulterUniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer IJuly 5, 2024
K232946horiba abxYumizen H2500May 21, 2024
K240636pixcell medical technologiesHemoScreen Hematology AnalyzerMay 2, 2024
K230887sysmex americaSysmex XQ-Series (XQ-320) Automated Hematology AnalyzerDecember 21, 2023
K230878ad astra diagnosticsQScout Lab; QScout RLDNovember 14, 2023
K222148pixcell medical technologiesHemoScreen Hematology AnalyzerAugust 16, 2023
K220031abbott laboratoriesAlinity h-series SystemAugust 4, 2023
K210346sysmex americaSysmex XW-100 Automated Hematology AnalyzerNovember 8, 2022
K211840s.d. sight diagnosticsSight OLOMay 9, 2022
K200828athelasAthelas HomeMarch 22, 2022
K193124beckman coulterUnicel DxH 800 Coulter Cellular Analysis SystemApril 16, 2020
K190898sight diagnosticsSight OLONovember 1, 2019
K182886beckman coulterCytomics FC 500 Series (MPL or MCL) Flow CytometerSeptember 6, 2019
K190294abbott laboratoriesCELL-DYN Emerald 22 AL SystemMarch 15, 2019