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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 BK010005
Tradename Chiron Procleix HIV/HCV Proficiency Panel
Device Name Kit, Test(Donors), For Bloodborne Pathogen
Original Applicant
Gen-Probe
10210 genetic center drive
san diego,  CA  92121 4362
Classification Product Code
MYZ  
Date Received03/01/2001
Decision Date 10/01/2001
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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