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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 BK140133
Tradename BloodTrack
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Haemonetics Corporation Software Solutions
4925 robert j. matthews parkway
suite 100
el dorado hills,  CA  95762
Regulation Number864.9165
Classification Product Code
MMH  
Date Received06/02/2014
Decision Date 08/29/2014
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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