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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cord blood processing system and storage container
510(k) Number BK070067
Tradename PrepaCyte(R)-CB Processing System
Device Name Cord blood processing system and storage container
Original Applicant
BioE, Inc.
4280 centerville road
st. paul,  MN  55127
Regulation Number864.9900
Classification Product Code
OAO  
Date Received11/23/2007
Decision Date 12/17/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
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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