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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 blood establishment computer software and accessories
510(k) Number BK030073
Tradename Configurable Manual Batch Entry 1.1A
Original Applicant
Rubin & Poor, Inc.
155 maplewood avenue #5
maplewood,  NJ  07040 US
Regulation Number864.9165
Classification Product Code
MMH  
Date Received11/06/2003
Decision Date 01/14/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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