Sysmex Corp. - FDA 510(k) Cleared Devices
18
Total
18
Cleared
0
Denied
Sysmex Corp. has 18 FDA 510(k) cleared hematology devices. Based in Mchenry, US.
Historical record: 18 cleared submissions from 1979 to 2001.
Browse the complete list of FDA 510(k) cleared hematology devices from this manufacturer. Filter by specialty or product code using the sidebar.
18 devices
Cleared
Sep 28, 2001
SYSMEX UF-50
Pathology
64d
Cleared
Nov 09, 1999
SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
Hematology
75d
Cleared
Nov 03, 1998
SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500
Hematology
153d
Cleared
Aug 14, 1998
SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
Hematology
87d
Cleared
Aug 26, 1997
SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER
Hematology
106d
Cleared
Mar 18, 1997
SYSMEX CA-1000/SYSMEX CA-5000
Hematology
98d
Cleared
Mar 13, 1997
SYSMEX SE/RAM-1
Hematology
132d
Cleared
Oct 28, 1996
SYSMEX UF-100
Pathology
224d
Cleared
Nov 03, 1995
SYSMEX SF-3000
Hematology
270d
Cleared
Jun 09, 1995
SYSMEX(TM) F-820, 520
Hematology
192d
Cleared
Mar 24, 1995
TOA MEDICAL ELECTRONICS CA-1000
Hematology
344d
Cleared
Mar 24, 1995
TOA MEDICAL ELECTRONICS CA-5000
Hematology
344d
Cleared
Feb 03, 1995
SYSMEX K-4500
Hematology
178d
Cleared
Feb 26, 1979
FLUID, RHEMOX W LYSING
Hematology
54d
Cleared
Feb 15, 1979
DILUENT, CELLENT BLOOD
Hematology
43d
Cleared
Feb 08, 1979
ANALYZER, MODEL CC-720
Hematology
36d
Cleared
Feb 08, 1979
SHAKER, MODEL SH-510
Chemistry
36d
Cleared
Feb 08, 1979
FLUID, RHEMOX-HB LYSING
Hematology
36d