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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 BK180198
Tradename AXP II AutoXpress Platform
Device Name Cord blood processing system and storage container
Original Applicant
ThermoGenesis Corp
2700 citrus rd
ranco cordova,  CA  75741
Regulation Number864.9900
Classification Product Code
OAO  
Date Received03/30/2018
Decision Date 11/14/2018
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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