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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 BK090074
Tradename Ortho Summit System
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 Received12/30/2008
Decision Date 05/27/2009
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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