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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 BK050042
Tradename Procleix System for 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 Received07/26/2005
Decision Date 11/15/2005
Decision substantially equivalent (SE)
Review Advisory Committee Immunology
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 Yes
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