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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 BK070007
Tradename PROCLEIX NAT TRACKER
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Chiron Corporation
4560 horton street
emeryville,  CA  94608 2916
Regulation Number864.9165
Classification Product Code
MMH  
Date Received02/09/2007
Decision Date 03/06/2007
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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