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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.
yoknaem ilit,  IL 2069202
Applicant Contact yaaya ben-yosef
Correspondent
Erika B. Ammirati, RAC, MT (ASCP)
575 Shirlynn Court
los altos,  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
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