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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 K111534
Device Name ABACUS 3CP
Applicant
Diatron U.S., Inc.
14026 W. 107th St.
Lenexa,  KS  66215 -2005
Applicant Contact MICHAEL SWITZER
Correspondent
Diatron U.S., Inc.
14026 W. 107th St.
Lenexa,  KS  66215 -2005
Correspondent Contact MICHAEL SWITZER
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received06/02/2011
Decision Date 08/02/2012
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
Recalls CDRH Recalls
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