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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 K120771
Model 629029
Device Name UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Original Applicant
BECKMAN COULTER, INC.
11800 sw 147th ave.
miami,  FL  33196 2500
Original Contact eric grace
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/14/2012
Decision Date 03/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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