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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 K260781
Device Name Yumizen H550
Applicant
HORIBA ABX SAS
Parc Euromedecine
Rue Du Caducee Bp7290
Montpellier,  FR 34184
Applicant Contact Christelle Calvo
Correspondent
HORIBA ABX SAS
Parc Euromedecine
Rue Du Caducee Bp7290
Montpellier,  FR 34184
Correspondent Contact Christelle Calvo
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/10/2026
Decision Date 09/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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