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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, equipment, automated bloodborne pathogen
510(k) Number BK050004
Tradename Procleix Optiva RAS
Device Name Test, Equipment, Automated Bloodborne Pathogen
Original Applicant
Chiron Corporation
4560 horton street
emeryville,  CA  94608 2916
Classification Product Code
MZA  
Date Received02/01/2005
Decision Date 04/08/2005
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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