Medical Device Manufacturer · US , San Diego , CA

Illumina, Inc. - FDA 510(k) Cleared Devices

6 submissions · 4 cleared · Since 2010
Official Website
6
Total
4
Cleared
2
Denied
FDA 510(k) Regulatory Record - Illumina, Inc. Pathology ✕
3 devices
1-3 of 3
Cleared Nov 19, 2013
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
K124006 · PFR
Pathology · 328d
Cleared Nov 19, 2013
ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
K132750 · PFS
Pathology · 77d
Cleared Apr 28, 2010
ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
K093129 · NPQ
Pathology · 208d
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