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510(k) K253212

XR-Series (XR-10, XR-20) Automated Hematology Analyzers by Sysmex America, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2026
Date Received
September 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

Other clearances by Sysmex America, Inc.

  • K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer (June 25, 2025)
  • K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer (June 25, 2025)
  • K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000) (June 2, 2025)
  • K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (December 21, 2023)
  • K210346 — Sysmex XW-100 Automated Hematology Analyzer (November 8, 2022)
  • K182389 — Sysmex XN-L Automated Hematology Analyzer (January 25, 2019)
  • K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (October 30, 2018)
  • K171883 — Sysmex UF-5000 Fully Automated Urine Particle Analyzer (April 23, 2018)
  • K172604 — XW-100 Automated Hematology Analyzer for CLIA Waived Use (November 6, 2017)
  • K160538 — Sysmex XN-L Automated Hematology Analyzer (December 22, 2016)

Other clearances for product code GKZ

  • K243348 — Athelas Home (February 6, 2026)
  • K251249 — Tru Hematology Test (January 16, 2026)
  • K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer (June 25, 2025)
  • K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer (June 25, 2025)
  • K243283 — Alinity h-series System (February 20, 2025)
  • K240402 — Cito CBC System (February 3, 2025)
  • K240252 — UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer I (July 5, 2024)
  • K232946 — Yumizen H2500 (May 21, 2024)
  • K240636 — HemoScreen Hematology Analyzer (May 2, 2024)
  • K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (December 21, 2023)