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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
PixCell Medical Technologies, Ltd.
6 Hayezira St.
Yoknaem Ilit,  IL 2069202
Applicant Contact Yaaya Ben-Yosef
Erika B. Ammirati, RAC, MT (ASCP)
575 Shirlynn Court
Los Altos,  CA  94022
Correspondent Contact Erika B. Ammirati
Regulation Number864.5220
Classification Product Code
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