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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 single (specified) analyte controls (assayed and unassayed)
510(k) Number BK070028
Tradename VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls
Device Name Single (Specified) Analyte Controls, (Assayed and Unassayed)
Original Applicant
Ortho-Clinical Diagnostics, Inc.
100 indigo creek drive
rochester,  NY  14626 5101
Regulation Number862.1660
Classification Product Code
JJX  
Date Received06/01/2007
Decision Date 04/10/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
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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