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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 BK040028
Tradename SoftBank II with SoftScape
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Soft Computer Consultants Inc.
34350 u.s. hwy 19 n.
palm harbor,  FL  34684
Regulation Number864.9165
Classification Product Code
MMH  
Date Received04/08/2004
Decision Date 05/07/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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