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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 kit, test (donors), for bloodborne pathogen
510(k) Number BK060022
Tradename ACCURUN 365 West Nile Virus RNA Positive Quality Control
Device Name Kit, Test(Donors), For Bloodborne Pathogen
Original Applicant
BBI Diagnostics, A SeraCare Company
375 west street
west bridgewater,  MA  02379
Classification Product Code
MYZ  
Date Received04/25/2006
Decision Date 06/12/2006
Decision substantially equivalent (SE)
Review Advisory Committee Immunology
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 Yes
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