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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 BK020060
Tradename NuclieSens HIV-1 QT RNA External Controls
Device Name Kit, Test(Donors), For Bloodborne Pathogen
Original Applicant
bioMerieux, Inc.
100 rodolphe street
durham,  NC  27712
Classification Product Code
MYZ  
Date Received11/18/2002
Decision Date 12/18/2002
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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