FDA 510(k) Applications Submitted by ILLUMINA, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K132750 09/03/2013 ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY ILLUMINA, INC.
K093128 10/02/2009 ILLUMINA BEADXPRESS SYSTEM ILLUMINA, INC.
K093129 10/02/2009 ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II ILLUMINA, INC.
DEN130011 09/23/2013 ILLUMINA MISEQDX PLATFORM ILLUMINA, INC.
DEN130042 10/04/2013 MISEQDX UNIVERSAL KIT 1.0 ILLUMINA, INC.
K124006 12/26/2012 ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY ILLUMINA, INC.


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