HemoScreen Hematology Analyzer

FDA 510(k) K240636 · Pixcell Medical Technologies

Substantially Equivalent

510(k) numberK240636

Submission

Device name
HemoScreen Hematology Analyzer
Applicant
Pixcell Medical Technologies
Yokneam Ilit, IL
Received
March 6, 2024
Decision date
May 2, 2024
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 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

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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
K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ · Traditional Sysmex America, Inc.12/21/2023SE

More from Sysmex America, Inc.

510(k)DeviceDecision
K222148HemoScreen Hematology AnalyzerGKZ · Traditional 08/16/2023SE
K180020HemoScreen Hematology AnalyzerGKZ · Traditional 10/29/2018SE

Questions and answers

When was HemoScreen Hematology Analyzer cleared by the FDA?

HemoScreen Hematology Analyzer (K240636) received a 510(k) decision of Substantially Equivalent on May 2, 2024, 57 days after the submission was received.

What is the product code of K240636?

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