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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 BK050044
Tradename Genetic Systems HIV-1/HIV-2 PLUS O Ortho Assay Protocol Disk
Device Name Test, Equipment, Automated Bloodborne Pathogen
Original Applicant
Ortho-Clinical Diagnostics, Inc.
1001 u.s. highway 202
raritan,  NJ  08869 0606
Classification Product Code
MZA  
Date Received08/08/2005
Decision Date 11/03/2006
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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