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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 K053308
Device Name ABX MICROS CRP 200, OPTION IM
Applicant
Horiba Abx
Parc Euromedecine
Rue Du Caducee
Montpellier,  FR 34184
Applicant Contact TIM LAWTON
Correspondent
Horiba Abx
Parc Euromedecine
Rue Du Caducee
Montpellier,  FR 34184
Correspondent Contact TIM LAWTON
Regulation Number864.5220
Classification Product Code
GKZ  
Subsequent Product Codes
DCK   JIS   JJX   JQP  
Date Received11/28/2005
Decision Date 12/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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