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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 BK080052
Tradename INSTRUMENT MANAGER
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Data Innovations LLC
120 kimball ave., suite 100
south burlington,  VT  05430
Regulation Number864.9165
Classification Product Code
MMH  
Date Received09/30/2008
Decision Date 10/28/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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