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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name software, blood virus applications
510(k) Number BK130020
Tradename ABBOTT PRISM Director
Device Name SOFTWARE, BLOOD VIRUS APPLICATION
Original Applicant
Abbott Laboratories
dept 09va, bldg ap8-1
100 abbott park road
abbott park,  IL  60064 3500
Classification Product Code
MTQ  
Date Received04/16/2013
Decision Date 05/14/2013
Decision substantially equivalent (SE)
Review Advisory Committee Hematology
Type 510(k) Special
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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