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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 BK820010
Tradename Animec
Device Name Device, Warming, Blood and Plasma
Original Applicant
Idas America Ltd.
lockview plaza
lockport,  NY  14094
Regulation Number864.9205
Classification Product Code
KZL  
Date Received08/18/1982
Decision Date 09/14/1982
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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