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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 test, equipment, automated bloodborne pathogen
510(k) Number BK060021
Tradename Procleix® TIGRIS® System for use with the Procleix® WNV Assay
Device Name Test, Equipment, Automated Bloodborne Pathogen
Original Applicant
Gen-Probe
10210 genetic center drive
san diego,  CA  92121 4362
Classification Product Code
MZA  
Date Received04/20/2006
Decision Date 02/20/2007
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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