Medical Device Manufacturer · US , Mundelein , IL

Sysmex America, Inc. - FDA 510(k) Cleared Devices

31 submissions · 31 cleared · Since 2003

Recent clearances: XR-Series (XR-10, XR-20) Automated Hematology Analyzers, Sysmex XR-Series (XR-10) Automated Hematology Analyzer, Sysmex XR-Series (XR-20) Automated Hematology Analyzer

31

Total

31

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sysmex America, Inc. Pathology ✕

4 devices

1-4 of 4

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