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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 K051215
Device Name CELL-DYN SAPPHIRE SYSTEM
Original Applicant
ABBOTT LABORATORIES
5440 patrick henry dr.
santa clara,  CA  95054
Original Contact michelle roeding
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received05/12/2005
Decision Date 07/21/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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