Medical Device Manufacturer · US , Mundelein , IL

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

30 submissions · 30 cleared · Since 2003

30

Total

30

Cleared

0

Denied

30 devices

26-30 of 30

Cleared Aug 08, 2005

IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100...

Hematology · 90d

Cleared May 04, 2005

RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER

Hematology · 57d

Cleared Mar 18, 2004

SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)

Hematology · 64d

Cleared Feb 11, 2004

SYSMEX POCH-100I

Hematology · 166d

Cleared Sep 08, 2003

IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED...

Hematology · 69d