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510k Database
Manufacturers
US
Sysmex Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Sysmex Corp. - FDA 510(k) Cleared Devices
18 submissions
·
18 cleared
·
Since 1979
18
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sysmex Corp.
Pathology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 28, 2001
SYSMEX UF-50
K012372
·
LKM
Pathology
·
64d
Cleared
Oct 28, 1996
SYSMEX UF-100
K961054
·
LKM
Pathology
·
224d
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18
Hematology
15
Pathology
2
Chemistry
1