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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
Applicant
ILLUMINA, INC.
9865 TOWNE CENTRE DRIVE
SAN DIEGO,  CA  92121 -1975
Applicant Contact DONALD R ELLIS
Correspondent
ILLUMINA, INC.
9865 TOWNE CENTRE DRIVE
SAN DIEGO,  CA  92121 -1975
Correspondent 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 (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Statement Statement
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00959504
Reviewed by Third Party No
Combination Product No
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