Sysmex Corp. - FDA 510(k) Cleared Devices
18
Total
18
Cleared
0
Denied
15 devices
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
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