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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 BK000036
Tradename R & D Leuko-Reduced Plt Control
Device Name Counter, Differential Cell
Original Applicant
R & D Systems, Inc
614 mckinley place n.e.
minneapolis,  MN  55413
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
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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