Sysmex America, Inc. - FDA 510(k) Cleared Devices
30
Total
30
Cleared
0
Denied
FDA 510(k) cleared devices by Sysmex America, Inc. Pathology ✕
4 devices
Cleared
Feb 03, 2009
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
Pathology
118d
Cleared
May 02, 2008
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
Pathology
32d
Cleared
May 25, 2007
SYSMEX MODEL UF1000I
Pathology
53d
Cleared
Jan 04, 2006
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
Pathology
57d