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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 K110381
Device Name CELL-DYN EMERALD 22 SYSTEM
Applicant
ABBOTT LABORATORIES
5440 PATRICK HENRY DR.
SANTA CLARA,  CA  95054
Applicant Contact MICHELLE B ROEDING
Correspondent
ABBOTT LABORATORIES
5440 PATRICK HENRY DR.
SANTA CLARA,  CA  95054
Correspondent Contact MICHELLE B ROEDING
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/10/2011
Decision Date 12/22/2011
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
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