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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K240636
Device Name HemoScreen Hematology Analyzer
Applicant
Pixcell Medical Technologies
Hayezira St., S. Industrial Zone
P.O. Box 1136
Yokneam Ilit,  IL 2069202
Applicant Contact Yaara Ben-Yosef
Correspondent
Zivd, LLC
62 Pollard
Plaistow,  NH  03865 -2532
Correspondent Contact Marcia L.Zucker
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/06/2024
Decision Date 05/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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