FDA.report

510(k) K222148

Device
HemoScreen Hematology Analyzer
Applicant
Pixcell Medical Technologies, Ltd.
510(k) number
K222148
Product code
GKZ
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-16
Date received
2022-07-20
Regulation
864.5220
Classification name
Counter, Differential Cell
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Yaara Ben Yosef
Address
6 Hayezira St. Yoknaem Ilit IL 2069202 2069202

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K240636HemoScreen Hematology AnalyzerPixcell Medical Technologies2024-05-02
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