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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 K141161
Device Name ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)
Applicant
HORIBA ABX SAS
Parc Euromedecine
Rue Du Caducee - Bp7290
Montpellier,  FR 34184
Applicant Contact FERRER CAROLINE
Correspondent
HORIBA ABX SAS
Parc Euromedecine
Rue Du Caducee - Bp7290
Montpellier,  FR 34184
Correspondent Contact FERRER CAROLINE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received05/05/2014
Decision Date 12/20/2014
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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