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510(k) K232946

Yumizen H2500 by HORIBA ABX SAS — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2024
Date Received
September 20, 2023
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 HORIBA ABX SAS

  • K193649 — Yumizen C1200 Creatinine PAP (May 10, 2021)
  • K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Im (June 26, 2020)
  • K192028 — Yumizen C1200 CRP (June 25, 2020)
  • K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Fact (March 6, 2020)
  • K191993 — Yumizen C1200 CRP (October 3, 2019)
  • K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin (August 30, 2019)
  • K191396 — Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (July 26, 2019)
  • K170353 — ABX MICROS ES 60 OT and ABX MICROS ES 60 CT (November 1, 2017)
  • K151133 — PENTRA XLR (December 9, 2015)
  • K141161 — ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) (December 20, 2014)

Other clearances for product code GKZ

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  • 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)
  • K240636 — HemoScreen Hematology Analyzer (May 2, 2024)
  • K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (December 21, 2023)
  • K230878 — QScout Lab; QScout RLD (November 14, 2023)