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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood establishment computer software and accessories
510(k) Number BK960026
Tradename Status Symbol TM II System Software
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
bioMerieux, Inc.
100 akzo avenue
durham,  NC  27712
Regulation Number864.9165
Classification Product Code
MMH  
Date Received03/27/1996
Decision Date 03/16/1999
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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