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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, warming. blood and plasma
510(k) Number BK030011
Tradename ThermoGenesis Thawer
Device Name Device, Warming, Blood and Plasma
Original Applicant
Thermogenesis
3146 gold camp drive
suite 206
rancho cordova,  CA  95670 6022
Regulation Number864.9205
Classification Product Code
KZL  
Date Received02/13/2003
Decision Date 06/10/2003
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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