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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name separator, automated, blood cell, diagnostic
510(k) Number BK100059
Tradename Harvest PRP Separation System
Device Name Automated Blood Cell Separators
Original Applicant
Harvest Technologies Corp
40 grissom road
plymouth,  MA  02360
Regulation Number864.9245
Classification Product Code
GKT  
Date Received10/22/2010
Decision Date 11/18/2010
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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