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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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
Current 510(k) Holder
No 510(k) holder with active listings
No 510(k) contact with active listings identified
Regulation Number864.9165
Classification Product Code
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