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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name test, factor v leiden mutations, genomic dna pcr
510(k) Number K093129
Device Name ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
Original Applicant
ILLUMINA, INC.
9865 towne centre drive
san diego,  CA  92121 1975
Original Contact donald r ellis
Regulation Number864.7280
Classification Product Code
NPQ  
Subsequent Product Code
NPR  
Date Received10/02/2009
Decision Date 04/28/2010
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
statement statement
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00959504
Reviewed by Third Party No
Expedited Review No
Combination Product No
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