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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 BK080006
Tradename IntelliDOT Blood Product Administration
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
IntelliDOT Corporation
13520 evening creek drive north,
suite 400
san diego,  CA  92128
Regulation Number864.9165
Classification Product Code
MMH  
Date Received02/11/2008
Decision Date 06/13/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
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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