Sysmex Xt-Series, Model XT-2000I and XT-1800I

FDA 510(k) K021241 · Sysmex Corporation of America

Substantially Equivalent

510(k) numberK021241

Submission

Device name
Sysmex Xt-Series, Model XT-2000I and XT-1800I
Applicant
Sysmex Corporation of America
Long Grove, IL, US
Received
April 19, 2002
Decision date
June 25, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GKZ – Counter, Differential Cell
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5220
Specialty
Hematology

Other 510(k)s with product code GKZ

510(k)DeviceApplicantDecision
K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional Sysmex America, Inc.05/27/2026SE
K243348Athelas HomeGKZ · Traditional Athelas, Inc.02/06/2026SE
K251249Tru Hematology TestGKZ · Traditional Truvian Sciences, Inc.01/16/2026SE
K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional Sysmex America, Inc.06/25/2025SE
K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional Sysmex America, Inc.06/25/2025SE
K243283Alinity h-series SystemGKZ · Traditional Abbott Laboratories02/20/2025SE
K240402Cito CBC SystemGKZ · Dual Track Cytochip, Inc.02/03/2025SE
K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…GKZ · Traditional Beckman Coulter, Inc.07/05/2024SE
K232946Yumizen H2500GKZ · Traditional Horiba Abx SAS05/21/2024SE
K240636HemoScreen Hematology AnalyzerGKZ · Abbreviated Pixcell Medical Technologies05/02/2024SE

More from Pixcell Medical Technologies

510(k)DeviceDecision
K020496HPC (Hematopoietic Progenitor Cell) Parameter on the Imi Channel of the Sysmex SE-9500…GKZ · Traditional 04/12/2002SE
K001683Sysmex R-500GKL · Traditional 08/21/2000SE

Questions and answers

When was Sysmex Xt-Series, Model XT-2000I and XT-1800I cleared by the FDA?

Sysmex Xt-Series, Model XT-2000I and XT-1800I (K021241) received a 510(k) decision of Substantially Equivalent on June 25, 2002, 67 days after the submission was received.

What is the product code of K021241?

The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.