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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name counter, differential cell
510(k) Number BK960087
Tradename ProCount Progenitor Cell Enumeration Kit
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 Received11/18/1996
Decision Date 06/04/1998
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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