Sysmex America, Inc. - FDA 510(k) Cleared Devices

Cleared Jun 25, 2025

Sysmex XR-Series (XR-10) Automated Hematology Analyzer

K250943 · GKZ

Hematology · 89d

Cleared Jun 25, 2025

Sysmex XR-Series (XR-20) Automated Hematology Analyzer

K251371 · GKZ

Hematology · 54d

Cleared Jun 02, 2025

Automated Blood Coagulation Analyzer CN-Series (CN-6000)

K250965 · JPA

Hematology · 63d

Cleared Dec 21, 2023

Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer

K230887 · GKZ

Hematology · 265d

Cleared Nov 08, 2022

Sysmex XW-100 Automated Hematology Analyzer

K210346 · GKZ

Hematology · 638d

Cleared Jan 25, 2019

Sysmex XN-L Automated Hematology Analyzer

K182389 · GKZ

Hematology · 143d

Cleared Oct 30, 2018

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device

K182062 · JOY

Hematology · 90d

Cleared Apr 23, 2018

Sysmex UF-5000 Fully Automated Urine Particle Analyzer

K171883 · LKM

Hematology · 304d

Cleared Nov 06, 2017

XW-100 Automated Hematology Analyzer for CLIA Waived Use

K172604 · GKZ

Hematology · 68d

Cleared Dec 22, 2016

Sysmex XN-L Automated Hematology Analyzer

K160538 · GKZ

Hematology · 300d

Cleared Oct 12, 2015

XW-100 Automated Hematology Analyzer, XW QC CHECK

K143577 · GKZ

Hematology · 299d

Cleared Dec 05, 2014

SYSMEX XN SERIES

K141681 · GKZ

Hematology · 165d