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Manufacturers
US
Nanosphere, Inc.
Medical Device Manufacturer
·
US , Northbrook , IL
Nanosphere, Inc. - FDA 510(k) Cleared Devices
16 submissions
·
15 cleared
·
Since 2007
16
Total
15
Cleared
1
Denied
FDA 510(k) Regulatory Record - Nanosphere, Inc.
Toxicology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 06, 2012
VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
K120466
·
NTI
Toxicology
·
265d
Cleared
Sep 17, 2007
VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
K070804
·
ODW
Toxicology
·
178d
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16
Microbiology
12
Toxicology
2
Pathology
1
Hematology
1