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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 BK050045
Tradename SoftDonor 4.3 with SoftScape
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
SCC Soft Computer
34350 u.s. highway 19 north
palm harbor,  FL  34684
Regulation Number864.9165
Classification Product Code
MMH  
Date Received08/15/2005
Decision Date 10/26/2005
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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