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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 BK000035
Tradename R & D Leuko-Reduced RBC Control
Device Name Automated Differential Cell Counter
Original Applicant
R & D Systems, Inc
614 mckinley place n.e.
minneapolis,  MN  55413 US
Original Contact kenneth t edds
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received07/31/2000
Decision Date 12/13/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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