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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 BK970046
Tradename LeucoCOUNT Reagent
Device Name Counter, Differential Cell
Original Applicant
Becton Dickinson Immunocytometry Systems
2350 qume drive
san jose,  CA  95131
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received12/22/1997
Decision Date 08/14/1998
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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