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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, processing for frozen blood
510(k) Number BK830003
Tradename IBM 2991 - Single Unit Leukocytes from Whole Blood
Device Name System, Processing for Frozen Blood
Original Applicant
International Business Machines
princeton,  NJ  08540
Regulation Number864.9145
Classification Product Code
KSW  
Date Received04/28/1983
Decision Date 05/27/1983
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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