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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 K024002
Device Name PENTRA 80
Applicant
ABX DIAGNOSTICS
PARC EUROMEDECINE
RUE DU CADUCEE
MONPELLIER,  FR 34184
Applicant Contact TIM LAWTON
Correspondent
ABX DIAGNOSTICS
PARC EUROMEDECINE
RUE DU CADUCEE
MONPELLIER,  FR 34184
Correspondent Contact TIM LAWTON
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received12/04/2002
Decision Date 01/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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