HemoScreen Hematology Analyzer

FDA 510(k) K222148 · Pixcell Medical Technologies, Ltd.

Substantially Equivalent

510(k) numberK222148

Submission

Device name
HemoScreen Hematology Analyzer
Applicant
Pixcell Medical Technologies, Ltd.
Yoknaem Ilit, IL
Received
July 20, 2022
Decision date
August 16, 2023
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
K240636HemoScreen Hematology AnalyzerGKZ · Abbreviated 05/02/2024SE
K180020HemoScreen Hematology AnalyzerGKZ · Traditional 10/29/2018SE

Questions and answers

When was HemoScreen Hematology Analyzer cleared by the FDA?

HemoScreen Hematology Analyzer (K222148) received a 510(k) decision of Substantially Equivalent on August 16, 2023, 392 days after the submission was received.

What is the product code of K222148?

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