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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 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 *
one becton drive
franklin lakes,  NJ  07417
Current 510(k) Contact * john tropin
Regulation Number864.5220
Classification Product Code
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