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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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