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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 test, qualitative, for hla, non-diagnostic
510(k) Number BK070038
Tradename AllSet Gold SSP
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
Life Technologies Corporation
9099 north deerbrook trail
brown deer,  WI  53223
Classification Product Code
MZI  
Date Received07/12/2007
Decision Date 09/26/2007
Decision substantially equivalent (SE)
Review Advisory Committee Hematology
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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