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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 K170353
Device Name ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
Applicant
HORIBA ABX SAS
Parc Euromedecine
Rue du Caducee BP 7290
Montpellier Cedex 4,  FR 34184
Applicant Contact Caroline Ferrer
Correspondent
HORIBA ABX SAS
Parc Euromedecine
Rue du Caducee BP 7290
Montpellier Cedex 4,  FR 34184
Correspondent Contact Caroline Ferrer
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/03/2017
Decision Date 11/01/2017
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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