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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 K112755
Device Name ABACUS 5
Applicant
DIATRON US INC
14026 W. 107TH STREET
LENEXA,  KS  66215 -2005
Applicant Contact MICHAEL SWITZER
Correspondent
DIATRON US INC
14026 W. 107TH STREET
LENEXA,  KS  66215 -2005
Correspondent Contact MICHAEL SWITZER
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received09/21/2011
Decision Date 03/27/2012
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
Recalls CDRH Recalls
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