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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 BK050059
Tradename BloodTrack Courier
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Neoteric Technology Ltd
205-1099 w. 8th ave.
vancouver,  British Columbia,  V6H 1C3, 
Regulation Number864.9165
Classification Product Code
MMH  
Date Received09/29/2005
Decision Date 12/13/2005
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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