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510k Database
Manufacturers
US
Illumina, Inc.
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.
Chemistry
✕
2
devices
1-2 of 2
Filters
Not Cleared
Nov 19, 2013
ILLUMINA MISEQDX PLATFORM
DEN130011
·
PFF
Chemistry
·
57d
Not Cleared
Nov 19, 2013
MISEQDX UNIVERSAL KIT 1.0
DEN130042
·
PFT
Chemistry
·
46d
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6
Pathology
3
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2
Hematology
1