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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 K232946
Device Name Yumizen H2500
Applicant
Horiba ABX Sas
Parc Euromedecine, Rue du Caducee BP7290
Montpellier Cedex 4,  FR 34184
Applicant Contact Caroline Ferrer
Correspondent
Horiba ABX Sas
Parc Euromedecine, Rue du Caducee BP7290
Montpellier Cedex 4,  FR 34184
Correspondent Contact Caroline Ferrer
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received09/20/2023
Decision Date 05/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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