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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 dna genetic analyzer
510(k) Number BK110039
Tradename 3500 Dx/3500 xL Dx Genetic Analyzer 8 CS2 and 3500 Dx Series Software
Device Name DNA Genetic Analyzer
Original Applicant
Life Technologies Corporation
9099 north deerbrook trail
brown deer,  WI  53223
Regulation Number862.2570
Classification Product Code
PCA  
Date Received08/02/2011
Decision Date 02/05/2013
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 No
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