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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 BK990005
Tradename StatusFlow Pro
Device Name Automated Differential Cell Counter
Original Applicant
R & D Systems, Inc
614 mckinley place n.e.
minneapolis,  MN  55413 US
Current 510(k) Holder *
BECTON, DICKINSON & CO.
one becton drive
franklin lakes,  NJ  07417
Current 510(k) Contact * john tropin
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/17/1999
Decision Date 06/21/1999
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
* Based on currently available data in Establishment Registration and Device Listing
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