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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 K961439
Device Name ABBOTT CELL-DYN 4000 SYSTEM
Original Applicant
ABBOTT DIAGNOSTICS
5440 patrick henry dr.
santa clara,  CA  95054
Original Contact janice e brown
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received04/15/1996
Decision Date 10/18/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Immunology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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