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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 K180020
Device Name HemoScreen Hematology Analyzer
Applicant
Pixcell Medical Technologies, Ltd.
6 Hayezira St.
Pob 113 Yoknaem Ilit,  IL 2069202
Applicant Contact Yaaya Ben-Yosef
Correspondent
Erika B. Ammirati, Rac, MT (Ascp)
575 Shirlynn Ct.
Los Angeles,  CA  94022
Correspondent Contact Erika B. Ammirati
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received01/02/2018
Decision Date 10/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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