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510k Database
Manufacturers
US
Sysmex America, Inc.
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Medical Device Manufacturer
·
US , Mundelein , IL
Sysmex America, Inc. - FDA 510(k) Cleared Devices
31 submissions
·
31 cleared
·
Since 2003
31
Total
31
Cleared
0
Denied
26
devices
26-26 of 26
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1
2
Cleared
Sep 08, 2003
IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED...
K032039
·
GKZ
Hematology
·
69d
1
2
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31
Hematology
26
Pathology
4
Chemistry
1